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Effects of Cervical Distraction Versus Cervical Traction Techniques on Upper Cervical Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional physical therapy with distraction technique
conventional physical therapy with traction technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Cervical pain, Traction, Distraction

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Minimum 3 months chronicity of upper cervical pain
  • Positive flexion-rotation test (asymmetry of >10◦ between sides or less than 32◦ in any direction)
  • hypomobility in one or more segments of C0-1, C1-2, or C2-3

Exclusion Criteria:

  • Congenital abnormalities (Cervical torticollis)
  • Past surgical history of cervical spine
  • Any history of neck trauma
  • Already undergone physiotherapy treatment

Sites / Locations

  • Mehmooda begum medical complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Distraction technique

Traction technique

Arm Description

conventional physical therapy with distraction technique

conventional physical therapy with traction technique

Outcomes

Primary Outcome Measures

NPRS
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain
NDI
The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50.
Goniometric measurement
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Neck flexion, extension, side bending and rotation will be assessed through it

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05393323
Brief Title
Effects of Cervical Distraction Versus Cervical Traction Techniques on Upper Cervical Pain
Official Title
Effects of Cervical Distraction Versus Cervical Traction Techniques on Pain, Range of Motion and Function in Patients With Upper Cervical Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International 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
The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A will receive cervical distraction technique with conventional physical therapy while Group B will receive cervical traction technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Both groups will receive 5 sessions per week for 4 weeks and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25
Detailed Description
The term collectively used for musculoskeletal conditions originating from cervical area is known as neck pain. According to the Global burden of disease (2010) study, neck pain is the fourth agent which is the reason behind chronic disability. The incidence of cervical pain in the adult population aged 15 to 74 years is 5.92% to 38.7% and it is more prevalent in women than men. The best predictor of future neck pain is the presence of an episode of neck pain in the past. Cervical rotation deficits are noted mostly in upper cervical spine issues as in atlantoaxial joint pathology. The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be a randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A will receive the cervical distraction technique with conventional physical therapy while Group B will receive the cervical traction technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Both groups will receive 5 sessions per week for 4 weeks and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Cervical pain, Traction, Distraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distraction technique
Arm Type
Experimental
Arm Description
conventional physical therapy with distraction technique
Arm Title
Traction technique
Arm Type
Experimental
Arm Description
conventional physical therapy with traction technique
Intervention Type
Other
Intervention Name(s)
conventional physical therapy with distraction technique
Intervention Description
Distraction will be at suboccipital level and patients will ask to assume a supine position with the head on the plinth. The therapist will use fingertips in both hands from digits 2 through 5, and cups the suboccipital region of the patient and supports the posterior skull. The therapist provides a light distraction to the posterior skull. Distraction will be applied for 10 min with pull for 10 sec and5 sec will be applied. Prior to apply this technique all patients will receive 15 minutes of infrared with TENS at cervical spine. The total treatment session will be of 25 minute with total intervention period of 4 weeks with 5 sessions per week.
Intervention Type
Other
Intervention Name(s)
conventional physical therapy with traction technique
Intervention Description
In cervical traction, patients will ask to lie supine on the treatment table. Head will cradle by physiotherapist from chin and the occiput, and then the physiotherapist will apply traction force in 25 degree neck flexion. Traction will be applied for 10 minutes with pull for 10 sec and 5 sec rest will be applied. Prior to apply this technique all patients will receive 15 minutes of infrared with TENS at cervical spine. The total treatment session will be of 25 min with total intervention period of 4 weeks with 5 sessions per week. All outcome measurements will be assessed before treatment and then reassessed at the end of 4th week.
Primary Outcome Measure Information:
Title
NPRS
Description
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain
Time Frame
4th week
Title
NDI
Description
The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50.
Time Frame
4th Week
Title
Goniometric measurement
Description
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Neck flexion, extension, side bending and rotation will be assessed through it
Time Frame
4th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum 3 months chronicity of upper cervical pain Positive flexion-rotation test (asymmetry of >10◦ between sides or less than 32◦ in any direction) hypomobility in one or more segments of C0-1, C1-2, or C2-3 Exclusion Criteria: Congenital abnormalities (Cervical torticollis) Past surgical history of cervical spine Any history of neck trauma Already undergone physiotherapy treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil-ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mehmooda begum medical complex
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Vaishy S, Kondal S. Effect of Vertical Cervical traction Combined with Conventional Neurodynamic Mobilization and SNAGs in an Individual with Neck Pain and Cervical Radiculopathy: A Case Report.
Results Reference
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Citation
Khan K, Yasmeen S, Ishaque F, Imdad F, Shaikh SA, Nawaz U, et al. A RANDOMIZED CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY OF MANUAL TRACTION ON PAIN AND RANGE OF MOTION IN CERVICAL RADICULOPATHY.
Results Reference
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PubMed Identifier
32035569
Citation
Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.
Results Reference
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Citation
Windsor RE, Malanga G, Benjamin M, Chawla J. Cervical spine anatomy. Medscape; 2017.
Results Reference
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PubMed Identifier
29480409
Citation
Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
Results Reference
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PubMed Identifier
32864219
Citation
Sillevis R, Hogg R. Anatomy and clinical relevance of sub occipital soft tissue connections with the dura mater in the upper cervical spine. PeerJ. 2020 Aug 10;8:e9716. doi: 10.7717/peerj.9716. eCollection 2020.
Results Reference
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PubMed Identifier
28750310
Citation
Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.
Results Reference
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PubMed Identifier
34900443
Citation
Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
Results Reference
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PubMed Identifier
32927858
Citation
Rodriguez-Sanz J, Malo-Urries M, Corral-de-Toro J, Lopez-de-Celis C, Lucha-Lopez MO, Tricas-Moreno JM, Lorente AI, Hidalgo-Garcia C. Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 10;17(18):6601. doi: 10.3390/ijerph17186601.
Results Reference
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PubMed Identifier
31511705
Citation
Afzal R, Ghous M, Shakil Ur Rehman S, Masood T. Comparison between Manual Traction, Manual Opening technique and Combination in Patients with cervical radiculopathy: Randomized Control Trial. J Pak Med Assoc. 2019 Sep;69(9):1237-1241.
Results Reference
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Effects of Cervical Distraction Versus Cervical Traction Techniques on Upper Cervical Pain

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