Cervical RadiculopathyNCT05234268
Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in Cervical Radiculopathy
A study testing Manual Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in people with Cervical Radiculopathy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
To determine the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Manual Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesPakistan
- Study dates
- 30 Jun 2021to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with cervical radiculopathy due to muscle tightness or spasm (Diagnosed by Spurling's Test)
- Having complaint more than 2 months
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Quaid-e-Azam International Hospital
Rawalpindi, Punjab Province, 45200.
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Manual Cervical Traction, Passive Accessory Intervertebral Movements, Active Strength Training
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Cervical TractionOther
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.
Passive Accessory Intervertebral MovementsOther
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.
Active Strength TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Cervical Traction | Experimental | 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. Receives: Other: Manual Cervical Traction |
| Passive Accessory Intervertebral Movements | Experimental | 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. Receives: Other: Passive Accessory Intervertebral Movements |
| Active Strength Training | Experimental | The progression of exercises will be done using different colours of Thera-band indicating varied resistance Receives: Other: Active Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
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".
Measured: 4 Weeks
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.
Measured: 4 Weeks
Secondary outcomes (2)
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.
Measured: 4 Weeks
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.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start30 Jun 2021
- Primary completion1 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234268
- Sponsor's protocol ID
- REC/01060 Yusra Arif
- Status last verified
- Sep 2022
- First submitted
- 1 Feb 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in the Management of Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT05234268
- Acronym / sponsor ID
- REC/01060 Yusra Arif
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Cervical Traction | Experimental | Other: Manual Cervical TractionThe 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. |
| Passive Accessory Intervertebral Movements | Experimental | Other: Passive Accessory Intervertebral MovementsPatient 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. |
| Active Strength Training | Experimental | Other: Active Strength TrainingThe progression of exercises will be done using different colours of Thera-band indicating varied resistance |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with cervical radiculopathy due to muscle tightness or spasm (Diagnosed by Spurling's Test)
- Having complaint more than 2 months
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Cervical TractionTime: 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. | Other | Manual Cervical Traction |
| Passive Accessory Intervertebral MovementsTime: 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. | Other | Passive Accessory Intervertebral Movements |
| Active Strength TrainingTime: 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. | Other | Active Strength Training |
Primary outcome
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).
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".
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.
2 secondary outcomes
Cervical Range of motion by Goniometer
Time frame: 4 Weeks
Endurance of the deep flexors of the cervical spine by Cranio-cervical Flexion Test
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Cervical Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
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Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy: A Randomized Controlled Trial
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Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
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Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Khalid, MSPT-OMPT principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in people with Cervical Radiculopathy, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief by Visual Analogue Scale (VAS) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.