Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in Cervical Radiculopathy

September 14, 2022 updated by: Riphah International University

Comparative Effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in the Management of Cervical Radiculopathy

To determine the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy. To compare the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy.

Study Overview

Detailed Description

Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots near the spinal cord. Some factors that may increase the risk for developing cervical radiculopathy include age. The risk for cervical radiculopathy tends to increase with age. This study is based on three interventions (Manual Cervical traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active Strength Training) individually on three separate but equal groups of participants. It will determine the most effective intervention and which intervention is superior to the other for treating cervical radiculopathy and to assist future practitioners and researchers.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Pakistan Railway General Hospital
      • Rawalpindi, Punjab, Pakistan, 45200.
        • Quaid-e-Azam International Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with cervical radiculopathy due to muscle tightness or spasm (Diagnosed by Spurling's Test)
  • Having complaint more than 2 months

Exclusion Criteria:

  • Past history of cervical surgery
  • Past history of cervical trauma
  • Any inflammatory disease
  • Tumor or Carcinoma
  • Disco genic/ disc herniation or stenosis cause of radiculopathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual Cervical Traction
The patient is in supine lying. The head and neck of patient are held in the hands of the practitioner, and then a gentle traction of a pulling force is applied. Intermittent periods of traction can be applied, holding each position for about 10 seconds. Traction is usually applied at about 20-30 degrees of neck flexion.

Time: 20 minutes Duration: thrice a week for 4 weeks.

Position:

The patient is in supine lying. The head and neck of patient are held in the hands of the practitioner, and then a gentle traction of a pulling force is applied. Intermittent periods of traction can be applied, holding each position for about 10 seconds. Traction is usually applied at about 20-30 degrees of neck flexion.

Experimental: Passive Accessory Intervertebral Movements
Patient lying in prone. Therapist stands to side of patient placing their pisiform/ulnar surface of hand over the selected spinous process (SP) with their wrist in full extension. Other hand placed on top of hand to reinforce. Therapist's shoulders should be directly above the SP with elbows slightly bent. Therapist uses their body weight to apply a PA force to the selected SP by leaning their body over their arms and performing rocking movements to provide oscillatory movements of the vertebra.

Time: 20 minutes Duration: thrice a week for 4 weeks

Position:

Patient lying in prone. Therapist stands to side of patient placing their pisiform/ulnar surface of hand over the selected spinous process (SP) with their wrist in full extension.

Other hand placed on top of hand to reinforce. Therapist's shoulders should be directly above the SP with elbows slightly bent. Therapist uses their body weight to apply a PA force to the selected SP by leaning their body over their arms and performing rocking movements to provide oscillatory movements of the vertebra.

Experimental: Active Strength Training
The progression of exercises will be done using different colours of Thera-band indicating varied resistance

Time: 20 minutes Duration: thrice a week for 4 weeks. The progression of exercises will be done using different colors of Thera-band indicating varied resistance. (A) Resistive lateral flexion of uninvolved side.

Position:

The patient is in sitting position. By the help of thera-band patient will actively flex the neck against resistance on the uninvolved side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relief by Visual Analogue Scale (VAS)
Time Frame: 4 weeks
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The simplest VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).
4 weeks
Activities of daily living by Neck Disability Index (NDI)
Time Frame: 4 Weeks

This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Patient-completed, condition- specific, functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.

Each section is scored on a 0 to 5 rating scale, in which zero means "no pain" and 5 means "Worst imaginable pain".

4 Weeks
Cervical Compression Test by Spurling's Test
Time Frame: 4 Weeks
The Spurling's test (also known as Maximal Cervical Compression Test and Foraminal Compression Test) is used during a musculoskeletal assessment of the cervical spine when looking for cervical nerve root compression causing Cervical Radiculopathy. There are different ways described in the literature to perform the Spurling's test. The version that provoked upper limb symptoms the best was with the neck in extension, lateral flexion and axial compression.
4 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Range of motion by Goniometer
Time Frame: 4 Weeks
A goniometer is an instrument which measures the available range of motion at a joint. Goniometer have different types; the most use is the universal standard goniometer, which is either made with plastic or metal tool. It consists of a stationary arm, a movable arm and a fulcrum.
4 Weeks
Endurance of the deep flexors of the cervical spine by Cranio-cervical Flexion Test
Time Frame: 4 week
The Craniocervical flexion test (CCFT) is a clinical test of neuromotor control including the activation and endurance of the deep flexors of the cervical spine. This test involves the subject performing a "yes" like nod which is the anatomical action of the Deep Cervical flexors, against a pressure biofeedback. The CCFT tests the neuromuscular control of the control of the deep cervical flexor muscles, the longus capitis, and colli. The test also assesses endurance of the deep cervical flexors and interaction of the deep cervical flexor muscles with the superficial flexors, i.e. the Sternocleidomastoid and the anterior scalene muscles. It can also be used as a clinical indicator of impaired activation of the deep cervical flexor muscles, to measure the muscle activity of the deep and superficial cervical muscles.
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maria Khalid, MSPT-OMPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 5, 2022

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • REC/01060 Yusra Arif

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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