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Manual Cervical Traction and Natural Apophyseal Glides for Cervical Radiculopathy Patients

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Natural apophyseal glides
Cervical manual traction
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Cervical radiculopathy, manual traction, neck pain

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects with clinically and radiologically diagnosed cervical radicular disease
  • Subjects with difficulties in carrying out daily activities due to radicular pain
  • Subject with bilateral/unilateral or both radicular pain
  • Both male, female patients between 20 and 60 years with the radicular pain

Exclusion Criteria:

  • Subjects having the mechanical cervical pain or the nonspecific pain of neck
  • Subjects having cervical myelopathy
  • Patients having any spine surgery or any malignancy
  • Subjects having pain because of postural imbalances

Sites / Locations

  • Physiotherapy Department of Mayo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Natural apophyseal glides

Cervical manual traction

Arm Description

This group receives natural apophyseal glides along with conventional physical therapy and manual techniques as treatment for 3 sessions per week on alternate days for 3 weeks

This group receives cervical manual traction along with conventional physical therapy and manual techniques as treatment for 3 sessions per week on alternate days for 3 weeks

Outcomes

Primary Outcome Measures

Change from Baseline in Numeric Pain Rating Scale
Pain intensity was measured using numeric pain rating scale
Change from Baseline in Neck Disability Index
Functional ability was measured using neck disability index

Secondary Outcome Measures

Full Information

First Posted
May 31, 2021
Last Updated
May 31, 2021
Sponsor
University of Lahore
Collaborators
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04915222
Brief Title
Manual Cervical Traction and Natural Apophyseal Glides for Cervical Radiculopathy Patients
Official Title
Comparison Between the Effectiveness of Manual Cervical Traction and Natural Apophyseal Glides on Pain and Disability Among Patients With Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
Collaborators
King Edward Medical 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
Cervical Radiculopathy is a clinical disorder of nerve root, and often is due to compressive or inflammatory pathology. There are number of different procedures which have been suggested for decreasing pain and disability in patients but manual therapy has been validated the effective technique. The objective of current research was to assess the comparative effectiveness of the Manual Cervical Traction and the Natural Apophyseal Glides on pain and disability among Cervical Radiculopathy patients. A parallel design, randomized controlled trial was performed on 72 patients in physiotherapy department, Mayo Hospital Lahore. Participants were randomly allocated into two groups after baseline testing. Group A received natural apophyseal glides and baseline treatment and group B received manual cervical traction and baseline treatment. Treatment period was of 3 weeks with 3 weekly sessions on alternate basis. Assessment was done before treatment at baseline and then by second and third week using numeric pain rating scale and neck disability index. SPSS version 25 was used to analyzed the data.
Detailed Description
72 patients who fulfill the inclusion criteria were enrolled in this study. Written informed consent was taken from every subject participating in this study. Allocation of subjects in two groups has been done by random number table as per CONSORT guidelines 2010. Group A was treated with Natural Apophyseal Glides and group B with Manual Cervical Traction. Both groups received the conventional therapy along with the manual techniques. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength.The conventional or baseline therapy remained same throughout the study. Group A received conventional therapy and NAGS with 2-3 hertz (less than 6 repetitions) in 3 sets for 3 weeks. Group B received MCT along with traditional therapy. Treatment frequency was 3 sessions per week for total three weeks duration. MCT applied was intermittent type traction.8 to 10 kg force was applied at an angle of 20 to 25 degree from horizontal. 5sets of cervical traction are performed. In every set traction is given for 1 minute with rest period of 20 seconds. The total time of session was 10 minute.Pain intensity was measured by Numeric Pain Rating Scale. Functional ability was appraised by Neck Disability Index. All the information was collected by using standardized questionnaire of NPRS and NDI. Confounding variables are controlled by randomization and restriction methods. All treatment was given by single handed to control the biasness.Proforma of the patients which dropout during study was filled through intention to treat analysis method which was set as 15%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Cervical radiculopathy, manual traction, neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center, parallel group randomized controlled trial of 72 participants.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Natural apophyseal glides
Arm Type
Experimental
Arm Description
This group receives natural apophyseal glides along with conventional physical therapy and manual techniques as treatment for 3 sessions per week on alternate days for 3 weeks
Arm Title
Cervical manual traction
Arm Type
Active Comparator
Arm Description
This group receives cervical manual traction along with conventional physical therapy and manual techniques as treatment for 3 sessions per week on alternate days for 3 weeks
Intervention Type
Other
Intervention Name(s)
Natural apophyseal glides
Intervention Description
Patients received conventional therapy and NAGS with 2-3 hertz (less than 6 repetitions) in 3 sets for 3 weeks. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength.
Intervention Type
Other
Intervention Name(s)
Cervical manual traction
Intervention Description
Patients received cervical manual traction (CMT) along with traditional therapy. Treatment frequency was 3 sessions per week for total three weeks duration. CMT applied was intermittent type traction.8 to 10 kg force was applied at an angle of 20 to 25 degree from horizontal. 5sets of cervical traction are performed. In every set traction is given for 1 minute with rest period of 20 seconds. The total time of traction session was 10 minute. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength.
Primary Outcome Measure Information:
Title
Change from Baseline in Numeric Pain Rating Scale
Description
Pain intensity was measured using numeric pain rating scale
Time Frame
Baseline and 3 weeks
Title
Change from Baseline in Neck Disability Index
Description
Functional ability was measured using neck disability index
Time Frame
Baseline and 3 weeks

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: Subjects with clinically and radiologically diagnosed cervical radicular disease Subjects with difficulties in carrying out daily activities due to radicular pain Subject with bilateral/unilateral or both radicular pain Both male, female patients between 20 and 60 years with the radicular pain Exclusion Criteria: Subjects having the mechanical cervical pain or the nonspecific pain of neck Subjects having cervical myelopathy Patients having any spine surgery or any malignancy Subjects having pain because of postural imbalances
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Ghazanfar
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy Department of Mayo Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data

Learn more about this trial

Manual Cervical Traction and Natural Apophyseal Glides for Cervical Radiculopathy Patients

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