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Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability

Primary Purpose

Cervical Disc Herniation, Pain, Neuropathic

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Combination Product: triamcinolone and saline
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Disc Herniation focused on measuring cervical disc herniation, epidural injection, radicular pain, neuropathic pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neck pain and / or unilateral arm pain for at least 3 months
  • Inadequate response to conservative treatment methods
  • Visual analog scale>5
  • Treatment of neuropathic pain:

Patients who received adequate treatment for a sufficient period of time (Gabapentine ( ≥4 wk ve ≥ 1200 mg) or Pregabaline ( ≥4 wk ve ≥ 300mg )) and did not respond adequately

Exclusion Criteria:

  • Cervical epidural injection history applied in the last 3 months
  • Presence of systemic and / or local infection
  • Bleeding diathesis
  • Pregnancy
  • Presence of a history of allergy to contrast agent and local anesthetic agent
  • Systemic inflammatory disease ( rheumatoid arthritis, SLE..)
  • Presence of malignancy
  • Presence of polyneuropathy, multiple sclerosis or demyelinating nervous system diseases
  • Patients with a history of surgical operations for cervical disc hernia and / or spinal stenosis
  • Patients with myelomalacia due to spinal cord compression

Sites / Locations

  • Feyza Nur YUCEL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cervical interlaminar epidural steroid injecion

Arm Description

Floroscopy-guided cervical interlaminar epidural steroid injecion will be applied to the patients with cervical radiculopathy related neck and arm pain

Outcomes

Primary Outcome Measures

Pain relief
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain relief
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain relief
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain relief
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.

Secondary Outcome Measures

Quality of life-Short form-12
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Quality of life-Short form-12
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Quality of life-Short form-12
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Quality of life-Short form-12
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Disability-Neck pain and disability scale (NPAD)
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Disability-Neck pain and disability scale (NPAD)
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Disability-Neck pain and disability scale (NPAD)
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Disability-Neck pain and disability scale (NPAD)
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
cervical range of motion (ROM) will be evaluated with a goniometer
cervical range of motion (ROM) will be evaluated with a goniometer all directions
cervical range of motion (ROM) will be evaluated with a goniometer
cervical range of motion (ROM) will be evaluated with a goniometer all directions
cervical range of motion (ROM) will be evaluated with a goniometer
cervical range of motion (ROM) will be evaluated with a goniometer all directions
cervical range of motion (ROM) will be evaluated with a goniometer
cervical range of motion (ROM) will be evaluated with a goniometer all directions
upper extremity motor exam
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
upper extremity motor exam
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
upper extremity motor exam
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
upper extremity motor exam
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed

Full Information

First Posted
January 16, 2020
Last Updated
February 18, 2020
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04235478
Brief Title
Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability
Official Title
The Evaluation of Effect of the Cervical İnterlaminar Epidural Steroid İnjection on Quality of Life, Neuropathic Pain and Disability in Patients With Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 27, 2017 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
February 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effect of cervical interlaminar epidural steroid injections on the neuropathic pain, quality of life and disability patients with cervical radiculopathy. After the clinical and MRG evaluations of patients with neck and arm pain, injection was given to eligible patients. Patients undergone the procedure were evaluated before and after injection for neuropathic pain, quality of life and disability.
Detailed Description
Neck and arm pain related to cervical radiculopathy is the second indication for epidural steroid injections after lumbar radiculopathy in the many a pain clinic. In this procedure corticosteroids and local anesthetics were given to the epidural space with fluoroscopy-guided special techniques. The underlying mechanism of action of these epidurally administered medications is not clear and ıt is believed to be due to anti-inflammatory properties of corticosteroids. In addition local anesthetics is thought to be as effective as corticosteroids in spinal pain of various origin. So far, many studies have shown the efficacy of these injections in acute/chronic pain of cervical radiculopathy. Although mixed pain is seen in most of patients, the relationship between pain pattern and treatment response is unclear. This study aims to evaluate the treatment responses of the patients who were diagnosed with neuropathic pain and the patients who weren't by means of LANSS. It is also intended to serach whether the presence of neuropathic pain will help to predict the treatment response or not. In this regard, the patients were evaluated with LANSS, SF-12 and neck pain and disability scale before the procedure. Categorized as the patients with neuropathic pain and the patients without, their treatment responses were compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Herniation, Pain, Neuropathic
Keywords
cervical disc herniation, epidural injection, radicular pain, neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical interlaminar epidural steroid injecion
Arm Type
Experimental
Arm Description
Floroscopy-guided cervical interlaminar epidural steroid injecion will be applied to the patients with cervical radiculopathy related neck and arm pain
Intervention Type
Drug
Intervention Name(s)
Combination Product: triamcinolone and saline
Other Intervention Name(s)
kenacort-a
Intervention Description
a mixture of 3 mL 0.09%saline and 2 mL 80 mg triamcinolone (kenacort-a)
Primary Outcome Measure Information:
Title
Pain relief
Description
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Time Frame
before treatment(T0)
Title
Pain relief
Description
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Time Frame
1th month after procedure (T1)
Title
Pain relief
Description
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Time Frame
3th month after procedure (T2)
Title
Pain relief
Description
Pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable) The primary outcome measure is reduction in initial VAS , treatment success was considered a 50% or more reduction in VAS point
Time Frame
6th month after procedure (T3)
Title
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
Description
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Time Frame
before treatment(T0)
Title
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
Description
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Time Frame
1th month after procedure (T1)
Title
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
Description
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Time Frame
3th month after procedure (T2)
Title
Pain classification-The leeds assesment of neuropathic signs&symptoms (LANSS)
Description
LANSS is an assessment tool that used to analyze and classify pain. The scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.According to various research reports, these LANSS tests correctly classified the patients as suffering from nociceptive and neuropathic pain, in four out of every five patients experiencing chronic pain. The validity and reliability of the questionnaire in Turkish were conducted by Yucel et al.
Time Frame
6th month after procedure (T3)
Secondary Outcome Measure Information:
Title
Quality of life-Short form-12
Description
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Time Frame
before treatment(T0)
Title
Quality of life-Short form-12
Description
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Time Frame
1th month after procedure (T1)
Title
Quality of life-Short form-12
Description
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Time Frame
3th month after procedure (T2)
Title
Quality of life-Short form-12
Description
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. The SF-12 consists of a subset of 12 items from the SF-36. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).SF-12 scales and summary measures are scored so that a higher score indicates a better health state.
Time Frame
6th month after procedure (T3)
Title
Disability-Neck pain and disability scale (NPAD)
Description
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Time Frame
before treatment(T0)
Title
Disability-Neck pain and disability scale (NPAD)
Description
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Time Frame
1th month after procedure (T1)
Title
Disability-Neck pain and disability scale (NPAD)
Description
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Time Frame
3th month after procedure (T2)
Title
Disability-Neck pain and disability scale (NPAD)
Description
The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability. Patients respond to each item by marking along a 10cm visual analog scale (VAS). Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)).a High scores are associated with increased disability.
Time Frame
6th month after procedure (T3)
Title
cervical range of motion (ROM) will be evaluated with a goniometer
Description
cervical range of motion (ROM) will be evaluated with a goniometer all directions
Time Frame
before treatment(T0)
Title
cervical range of motion (ROM) will be evaluated with a goniometer
Description
cervical range of motion (ROM) will be evaluated with a goniometer all directions
Time Frame
1th month after procedure (T1)
Title
cervical range of motion (ROM) will be evaluated with a goniometer
Description
cervical range of motion (ROM) will be evaluated with a goniometer all directions
Time Frame
3th month after procedure (T2)
Title
cervical range of motion (ROM) will be evaluated with a goniometer
Description
cervical range of motion (ROM) will be evaluated with a goniometer all directions
Time Frame
6th month after procedure (T3)
Title
upper extremity motor exam
Description
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
Time Frame
before treatment(T0)
Title
upper extremity motor exam
Description
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
Time Frame
1th month after procedure (T1)
Title
upper extremity motor exam
Description
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
Time Frame
3th month after procedure (T2)
Title
upper extremity motor exam
Description
Muscle strength is tested from the proximal to the distal part of the upper extremity so that all segmental levels for the extremity will be tested according to the a scale of 0/5 to 5/5. İn addition upper extremity deep tendon relfex will also evalutaed
Time Frame
6th month after procedure (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neck pain and / or unilateral arm pain for at least 3 months Inadequate response to conservative treatment methods Visual analog scale>5 Treatment of neuropathic pain: Patients who received adequate treatment for a sufficient period of time (Gabapentine ( ≥4 wk ve ≥ 1200 mg) or Pregabaline ( ≥4 wk ve ≥ 300mg )) and did not respond adequately Exclusion Criteria: Cervical epidural injection history applied in the last 3 months Presence of systemic and / or local infection Bleeding diathesis Pregnancy Presence of a history of allergy to contrast agent and local anesthetic agent Systemic inflammatory disease ( rheumatoid arthritis, SLE..) Presence of malignancy Presence of polyneuropathy, multiple sclerosis or demyelinating nervous system diseases Patients with a history of surgical operations for cervical disc hernia and / or spinal stenosis Patients with myelomalacia due to spinal cord compression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savaş ŞENCAN, Asst. Prof
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feyza Nur YUCEL
City
İstanbul
ZIP/Postal Code
34899
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Turner-Bowker D., Hogue S.J. (2014) Short Form 12 Health Survey (SF-12). In: Michalos A.C. (eds) Encyclopedia of Quality of Life and Well-Being Research. Springer, Dordrecht
Results Reference
background
PubMed Identifier
25675059
Citation
Manchikanti L, Nampiaparampil DE, Candido KD, Bakshi S, Grider JS, Falco FJ, Sehgal N, Hirsch JA. Do cervical epidural injections provide long-term relief in neck and upper extremity pain? A systematic review. Pain Physician. 2015 Jan-Feb;18(1):39-60.
Results Reference
result
PubMed Identifier
15501424
Citation
Yucel A, Senocak M, Kocasoy Orhan E, Cimen A, Ertas M. Results of the Leeds assessment of neuropathic symptoms and signs pain scale in Turkey: a validation study. J Pain. 2004 Oct;5(8):427-32. doi: 10.1016/j.jpain.2004.07.001.
Results Reference
result
PubMed Identifier
33655971
Citation
Sanal-Toprak C, Ozturk EC, Yucel FN, Sencan S, Gunduz OH. Does the presence of neuropathic pain affect the outcomes of the interlaminar epidural steroid injection for cervical disc herniation?: A prospective clinical study. Medicine (Baltimore). 2021 Mar 5;100(9):e25012. doi: 10.1097/MD.0000000000025012.
Results Reference
derived

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Effect of the Cervical Interlaminar Epidural Steroid Injection on Quality of Life, Pain and Disability

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