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

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Manual Cervical Traction
Passive Accessory Intervertebral Movements
Active Strength Training
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

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Quaid-e-Azam International Hospital
  • Pakistan Railway General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Manual Cervical Traction

Passive Accessory Intervertebral Movements

Active Strength Training

Arm Description

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.

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.

The progression of exercises will be done using different colours of Thera-band indicating varied resistance

Outcomes

Primary Outcome Measures

Pain Relief by Visual Analogue Scale (VAS)
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).
Activities of daily living by Neck Disability Index (NDI)
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".
Cervical Compression Test by Spurling's Test
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.

Secondary Outcome Measures

Cervical Range of motion by Goniometer
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.
Endurance of the deep flexors of the cervical spine by Cranio-cervical Flexion Test
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.

Full Information

First Posted
February 1, 2022
Last Updated
September 14, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05234268
Brief Title
Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in Cervical Radiculopathy
Official Title
Comparative Effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in the Management of Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 5, 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
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.
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.

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
Participant
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Cervical Traction
Arm Type
Experimental
Arm Description
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.
Arm Title
Passive Accessory Intervertebral Movements
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Strength Training
Arm Type
Experimental
Arm Description
The progression of exercises will be done using different colours of Thera-band indicating varied resistance
Intervention Type
Other
Intervention Name(s)
Manual Cervical Traction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Passive Accessory Intervertebral Movements
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Active Strength Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Relief by Visual Analogue Scale (VAS)
Description
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).
Time Frame
4 weeks
Title
Activities of daily living by Neck Disability Index (NDI)
Description
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".
Time Frame
4 Weeks
Title
Cervical Compression Test by Spurling's Test
Description
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.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Cervical Range of motion by Goniometer
Description
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.
Time Frame
4 Weeks
Title
Endurance of the deep flexors of the cervical spine by Cranio-cervical Flexion Test
Description
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.
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Khalid, MSPT-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quaid-e-Azam International Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
45200.
Country
Pakistan
Facility Name
Pakistan Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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