search
Back to results

Simultaneous Traction and Neural Mobilization

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Simultaneous Cervical Traction & Neural Mobilization
consecutive Cervical Traction & Neural Mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with Chronic Cervical Radiculopathy for 6 months will be included.
  • Participants with Positive Spurling and Upper Limb Neural Tension Tests (ULNTTs) will be included.
  • Participants of age 20 to 60 will be included

Exclusion Criteria:

  • The participants with cervical myelopathy and other pathologies will not be included.
  • The participants with Vertigo/dizziness will not be included.
  • The participants with bilateral symptoms will not be included.
  • The participants with other musculoskeletal conditions in the affected limb will not be included.

Sites / Locations

  • The Physiotherapy Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simultaneous Cervical Traction & Neural Mobilization

consecutive Cervical Traction & Neural Mobilization

Arm Description

Traction is a maneuver of distracting force to the cervical spine to cervical segments/grants decompression of nerve roots. For traction, 10% of the total body weight would be taken. Previous researches that investigated cervical traction found adequate effectiveness on pain reduction in neck and arm as well as improvement in nerve function parameters, and enhancement in neck mobility. The patient would be placed in a supine lying position with the cervical spine placed at 15º of flexion. The head strap will be fitted under the patient's occiput and chin. A safety switch will be given to the patient and ask him to press it if he would feel any kind of discomfort.

the same description is for active comparator except for treatment mode to consecutive.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
NPRS for pain is a unidimensional measure of pain intensity. Similar to visual analogue scale (VAS), the NPRS is anchored by describing pain severity extremes. The NPRS can be administered verbally or graphically for self-completion.
Neck Disability Index (NDI) for function
NDI used to measure cervical pain and functional disability. The NDI was created using a questionnaire with 10 questions based on the Oswestry Index, which evaluates restrictions to ordinary life in relation to lumbar pain. The subjects selected a score of one to six (0 to 5) in 10 items: reading, headache, concentration, work, driving, sleeping, leisure life, pain intensity, ordinary life, and raising an object. The higher the sum of each item's score, the more severe the functional disability related to cervical abnormality. Zero to four points, five to 14 points, 15 to 24 points, 25 to 34 points, and 35 points or higher signify no disability, weak disability, moderate disability, severe disability, and complete disability, respectively
Short Form Quality of Life 12: (physical, mental)
The developers of short form (SF) 36 have consequently, suggested that a 12 item sub-set of the items may accurately reproduce the two summary component scores which can be derived from the SF 36 [the physical component score (PCS) and the mental component score (MCS)]. The scores were put in the free online orthopedic calculator "ortho tool kit" and two summary scores have been generated: Physical component score and mental component score.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2021
Last Updated
February 23, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05021510
Brief Title
Simultaneous Traction and Neural Mobilization
Official Title
Effects of Simultaneous Traction and Neural Mobilization on Pain and Function in Cervical Radiculopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
August 20, 2022 (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
Yes

5. Study Description

Brief Summary
Neck pain is a frequently reported complaint of the musculoskeletal system which generally has a huge impact on health care expenditure; ascribed to visits to health care providers, disability, and sick leaves. A variety of manual therapy techniques including Cervical traction (CT) and neural mobilization techniques (NMTs) have been prescribed in the management of CR because of their immediate analgesic effect. Both techniques have been proposed to reduce pain and functional limitations in CR. Traction increases the separation of the vertebral bodies which eventually reduces the central pressure in the disk space and encourages the disk nucleus to get back to a central position. The current literature lends assistance to the utilization of the traction in addition to other physical therapy procedures for pain reduction, with less significant impact on function and disability. Further studies should investigate to explore the most effective traction method and dosage, the subgroups of patients with CR, or the pain stage (acute, subacute, or chronic) most benefited by this intervention and the physical therapy procedures that yield the most effective outcomes when combined with traction.
Detailed Description
Researchers have started exploring that neural tissue mobilization along with conventional treatment is more effective in decreasing pain and improving cervical range of motion and mental component of quality of life in unilateral cervical radiculopathy (CR) patients than intermittent cervical traction and conventional treatment. Future randomized controlled trials are warranted with the purpose to compare the long-term effectiveness of cervical traction with neural mobilization in CR, as well as the effect of these two techniques in comparison with other interventions. Some literature recommended the simultaneous application of mechanical cervical traction along with neural mobilization in the treatment of Unilateral Cervical Radiculopathy. There are numerous studies in which both groups received Cervical traction (CT) and neural mobilization (NM) was added in only one group along with cervical traction or studies in which both groups received NM and CT was administered in only one group as well, there are also some studies in which one group received only CT and other group received only NM but there isn't any study yet in which we can compare the effect of simultaneous administration of CT and NM and consecutive administration of CT and NM. Pain and functional limitation in cervical radiculopathy can be treated with mechanical cervical traction and neural mobilization. The purpose of the study is to determine that is simultaneous administration of cervical traction and neural mobilization is more effective than consecutive administration in the management of cervical radiculopathy. The findings of the study will provide an insight into the low-cost evidence-based conservative management of cervical radiculopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Simultaneous Cervical Traction & Neural Mobilization
Arm Type
Experimental
Arm Description
Traction is a maneuver of distracting force to the cervical spine to cervical segments/grants decompression of nerve roots. For traction, 10% of the total body weight would be taken. Previous researches that investigated cervical traction found adequate effectiveness on pain reduction in neck and arm as well as improvement in nerve function parameters, and enhancement in neck mobility. The patient would be placed in a supine lying position with the cervical spine placed at 15º of flexion. The head strap will be fitted under the patient's occiput and chin. A safety switch will be given to the patient and ask him to press it if he would feel any kind of discomfort.
Arm Title
consecutive Cervical Traction & Neural Mobilization
Arm Type
Active Comparator
Arm Description
the same description is for active comparator except for treatment mode to consecutive.
Intervention Type
Other
Intervention Name(s)
Simultaneous Cervical Traction & Neural Mobilization
Intervention Description
Simultaneously Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks
Intervention Type
Other
Intervention Name(s)
consecutive Cervical Traction & Neural Mobilization
Intervention Description
consecutive Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
NPRS for pain is a unidimensional measure of pain intensity. Similar to visual analogue scale (VAS), the NPRS is anchored by describing pain severity extremes. The NPRS can be administered verbally or graphically for self-completion.
Time Frame
week 4
Title
Neck Disability Index (NDI) for function
Description
NDI used to measure cervical pain and functional disability. The NDI was created using a questionnaire with 10 questions based on the Oswestry Index, which evaluates restrictions to ordinary life in relation to lumbar pain. The subjects selected a score of one to six (0 to 5) in 10 items: reading, headache, concentration, work, driving, sleeping, leisure life, pain intensity, ordinary life, and raising an object. The higher the sum of each item's score, the more severe the functional disability related to cervical abnormality. Zero to four points, five to 14 points, 15 to 24 points, 25 to 34 points, and 35 points or higher signify no disability, weak disability, moderate disability, severe disability, and complete disability, respectively
Time Frame
week 4
Title
Short Form Quality of Life 12: (physical, mental)
Description
The developers of short form (SF) 36 have consequently, suggested that a 12 item sub-set of the items may accurately reproduce the two summary component scores which can be derived from the SF 36 [the physical component score (PCS) and the mental component score (MCS)]. The scores were put in the free online orthopedic calculator "ortho tool kit" and two summary scores have been generated: Physical component score and mental component score.
Time Frame
week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with Chronic Cervical Radiculopathy for 6 months will be included. Participants with Positive Spurling and Upper Limb Neural Tension Tests (ULNTTs) will be included. Participants of age 20 to 60 will be included Exclusion Criteria: The participants with cervical myelopathy and other pathologies will not be included. The participants with Vertigo/dizziness will not be included. The participants with bilateral symptoms will not be included. The participants with other musculoskeletal conditions in the affected limb will not be included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arshad Malik, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Physiotherapy Clinic
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25659245
Citation
Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
Results Reference
background
PubMed Identifier
30664500
Citation
Ayub A, Osama M, Ahmad S. Effects of active versus passive upper extremity neural mobilization combined with mechanical traction and joint mobilization in females with cervical radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(5):725-730. doi: 10.3233/BMR-170887.
Results Reference
background
PubMed Identifier
33992259
Citation
Savva C, Korakakis V, Efstathiou M, Karagiannis C. Cervical traction combined with neural mobilization for patients with cervical radiculopathy: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:279-289. doi: 10.1016/j.jbmt.2020.08.019. Epub 2020 Sep 2.
Results Reference
background
PubMed Identifier
30395087
Citation
Tarazona D, Boody B, Hilibrand AS, Stull J, Bell K, Fang T, Goyal D, Galetta M, Kaye D, Kepler CK, Kurd MF, Woods BI, Radcliff KE, Rihn JA, Anderson DG, Vaccaro AR, Schroeder GD. Longer Preoperative Duration of Symptoms Negatively Affects Health-related Quality of Life After Surgery for Cervical Radiculopathy. Spine (Phila Pa 1976). 2019 May 15;44(10):685-690. doi: 10.1097/BRS.0000000000002924.
Results Reference
background
PubMed Identifier
25892373
Citation
Efstathiou MA, Stefanakis M, Savva C, Giakas G. Effectiveness of neural mobilization in patients with spinal radiculopathy: a critical review. J Bodyw Mov Ther. 2015 Apr;19(2):205-12. doi: 10.1016/j.jbmt.2014.08.006. Epub 2014 Aug 17.
Results Reference
background
PubMed Identifier
29315428
Citation
Romeo A, Vanti C, Boldrini V, Ruggeri M, Guccione AA, Pillastrini P, Bertozzi L. Cervical Radiculopathy: Effectiveness of Adding Traction to Physical Therapy-A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Apr 1;98(4):231-242. doi: 10.1093/physth/pzy001. Erratum In: Phys Ther. 2018 Aug 1;98(8):727.
Results Reference
background
PubMed Identifier
23024624
Citation
Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.
Results Reference
background

Learn more about this trial

Simultaneous Traction and Neural Mobilization

We'll reach out to this number within 24 hrs