NCT04915222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
Last Updated

June 7, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 31, 2021

Last Update Submit

May 31, 2021

Conditions

Keywords

Cervical radiculopathymanual tractionneck pain

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Numeric Pain Rating Scale

    Pain intensity was measured using numeric pain rating scale

    Baseline and 3 weeks

  • Change from Baseline in Neck Disability Index

    Functional ability was measured using neck disability index

    Baseline and 3 weeks

Study Arms (2)

Natural apophyseal glides

EXPERIMENTAL

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

Other: Natural apophyseal glides

Cervical manual traction

ACTIVE COMPARATOR

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

Other: Cervical manual traction

Interventions

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.

Natural apophyseal glides

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.

Cervical manual traction

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy Department of Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

RadiculopathyNeck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mariam Ghazanfar

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single center, parallel group randomized controlled trial of 72 participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 7, 2021

Study Start

September 10, 2018

Primary Completion

March 15, 2019

Study Completion

March 15, 2019

Last Updated

June 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data

Locations