- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05234268
Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in Cervical Radiculopathy
Comparative Effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in the Management of Cervical Radiculopathy
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Pakistan Railway General Hospital
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Rawalpindi, Punjab, Pakistan, 45200.
- Quaid-e-Azam International Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Maria Khalid, MSPT-OMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01060 Yusra Arif
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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