Cervical RadiculopathyNCT05352464
Effects of Cervical Traction With and Without EMG Biofeedback in Patients With Cervical Radiculopathy
A study testing cervical traction with EMG biofeedback and cervical traction and conventional physical therapy in people with Cervical Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cervical radiculopathy is a neurological condition which is caused by underlying musculoskeletal disorders including herniated disc and degenerative changes in cervical spine that results in narrowing or stenosis of intervertebral foramen. This narrowing leads to compression of nerve root at the respective foramen. 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?
- cervical traction with EMG biofeedback and cervical traction and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 19 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
- Symptoms duration was more than one month up to six months.
- Radiculopathy due to muscle spasm.
- Radiculopathy due to postero-lateral disc herniation.
- Pain radiating with numbness and tingling sensations to both arms, forearms and hands.
Who cannot join
- Patients diagnosed with thoracic outlet syndrome, diabetes mellitus, and/or carpel tunnel syndrome.
- Patients had severe sensory and/or motor manifestations.
- Patients had manifestations of central cervical disc herniation.
- Congenital conditions of the cervical spine.
- Patients with contraindications to mobilization techniques and those with dizziness due to vertebrobasilar insufficiency or vestibular dysfunctions.
- Cervical Fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Cervical radiculopathy is a neurological condition which is caused by underlying musculoskeletal disorders including herniated disc and degenerative changes in cervical spine that results in narrowing or stenosis of intervertebral foramen. This narrowing leads to compression of nerve root at the respective foramen. The compressed nerve root produces symptoms like numbness, tingling, pain and motor weakness in neck and upper extremity. These symptoms appear at the dermatome and myotome distribution of the affected nerve root. Mostly the cervical radiculopathy is present unilaterally but in severe cases it can appear bilaterally where bony spurs are found at various levels and nerve root in under compression on both sides.
Read the detailed description
Cervical radiculopathy is a neurological condition which is caused by underlying musculoskeletal disorders including herniated disc and degenerative changes in cervical spine that results in narrowing or stenosis of intervertebral foramen. This narrowing leads to compression of nerve root at the respective foramen. The compressed nerve root produces symptoms like numbness, tingling, pain and motor weakness in neck and upper extremity. These symptoms appear at the dermatome and myotome distribution of the affected nerve root. Mostly the cervical radiculopathy is present unilaterally but in severe cases it can appear bilaterally where bony spurs are found at various levels and nerve root in under compression on both sides.
The annual incidence rate of cervical radiculopathy is reported to be 107.3 per 100,000 of men and 63.5 per 100,000 of women. So accordingly, the condition is more common in males than females.
Although no definitive treatment plan for cervical radiculopathy has been developed, there is a general consensus in the literature that using manual therapy techniques in conjunction with therapeutic exercise is effective in terms of increasing function and active range of motion (AROM). The focus will most likely be on reducing pain and disability. Recent researches have shown that exercise therapy has the highest beneficial outcomes.
Treatment options for rehabilitation plan includes: Education and advice, Manual Therapy - PAIVMs (Passive Accessory Intervertebral Movements) / PPIVMs (Passive Physiological Intervertebral Movements) / NAGs (Natural Apophyseal Glides) / SNAGs (Sustained Natural Apophyseal Glides),Exercise Therapy - AROM, stretching and strengthening and Postural re-education Cervical traction and electromyography (EMG) biofeedback have been administered by many physiotherapists and positive outcomes are revealed. Traction not only relives nerve root compression but also helps in managing acute pain instantly whereas EMG biofeedback is used to generate an electrical feedback signal in response to muscle activation and helps patients to learn a more effective way of using their weak muscles
- Conditions
- Cervical Radiculopathy
- Being tested
- cervical traction with EMG biofeedback, cervical traction and conventional physical therapy
- Keywords
- cervical traction, Range of motion, pain, EMG biofeedback, disability
- Medical subject headings
- Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical traction with EMG biofeedbackOther
Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position.
Ask the patient to assume sitting position on a comfortable chair. Place surface electrodes of EMG biofeedback at the level of C5-6 Para spinal muscles to pick up the activity of the muscles and convert it to vis-ual and auditory impulses produced from the device. Tell the patient to try to relax the tension of the neck muscles as much as he can by lowering the visual and auditory impulses from the device
cervical traction and conventional physical therapyOther
Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position
| Study group | Role | What they receive |
|---|---|---|
| cervical traction with EMG biofeedback | Experimental | Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position.
Ask the patient to assume sitting position on a comfortable chair. Place surface electrodes of EMG biofeedback at the level of C5-6 Para spinal muscles to pick up the activity of the muscles and convert it to vis-ual and auditory impulses produced from the device. Tell the patient to try to relax the tension of the neck muscles as much as he can by lowering the visual and auditory impulses from the device Receives: Other: cervical traction with EMG biofeedback |
| cervical traction and conventional physical therapy | Active comparator | Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position. Receives: Other: cervical traction and conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS):
It is a subjective tool used to measure intensity of pain. It starts from 0 meaning "No pain" to 10 meaning "Worst pain". The reliability and validity of VAS measured by ICC is 0.97 and 0.941 respectively.Assesment to be done on baseline,2nd week,4th week and 6th week.
Measured: for six weeks
Neck Disability Index (NDI)
It is also a subjective tool used to evaluate neck disability. It ranks from 0 meaning "No pain" to 5 meaning "Worst imaginable pain". The reliability and validity if NDI measured by Cronbach's alpha is 0.89 and 0.60-0.70 respectively. Assessment to be done at baseline,2nd week,4th week and 6th week.
Measured: for six weeks
EMG biofeedback
It is an electric device use to generate electrical feedback signals from activation of muscles. The reliability and validity of EMG biofeedback is 0.815-0.979 (19) and 0.781-0.907 respectively.Assesment to be done at baseline,2nd week,4th week and 6th week.
Measured: for six weeks
Inclinometer.
Inclinometers have dials or digital readouts that display the angle at which the inclinometer is situated relative to the line of gravity.
Inclinometer measurements of cervical flexion, extension, lateral flexion, and rotation were found to be reliable for all three methods with ICCs ranging from 0.89 to 0.94.Assesment to be done at baseline,2nd week,4th week and 6th week.
Measured: for six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Apr 2022
- Primary completion15 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352464
- Sponsor's protocol ID
- REC -01052 Sana Sabir
- Status last verified
- Sep 2022
- First submitted
- 25 Apr 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sabir S, Khalid M, Khan KA, Qazi ZN, Obaid S, Khawar S. Effects of cervical traction with and without EMG biofeedback in patients with cervical radiculopathy- A randomised controlled trial. J Pak Med Assoc. 2026 Mar;76(3):308-315. doi: 10.47391/JPMA.21396.
PubMed 42017707
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Traction With and Without EMG Biofeedback in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT05352464
- Acronym / sponsor ID
- REC -01052 Sana Sabir
- Conditions
- Cervical Radiculopathy
- Keywords
- cervical traction, Range of motion, pain, EMG biofeedback, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 28 Apr 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.
Cervical radiculopathy is a neurological condition which is caused by underlying musculoskeletal disorders including herniated disc and degenerative changes in cervical spine that results in narrowing or stenosis of intervertebral foramen. This narrowing leads to compression of nerve root at the respective foramen. The compressed nerve root produces symptoms like numbness, tingling, pain and motor weakness in neck and upper extremity. These symptoms appear at the dermatome and myotome distribution of the affected nerve root. Mostly the cervical radiculopathy is present unilaterally but in severe cases it can appear bilaterally where bony spurs are found at various levels and nerve root in under compression on both sides.
Detailed description
Cervical radiculopathy is a neurological condition which is caused by underlying musculoskeletal disorders including herniated disc and degenerative changes in cervical spine that results in narrowing or stenosis of intervertebral foramen. This narrowing leads to compression of nerve root at the respective foramen. The compressed nerve root produces symptoms like numbness, tingling, pain and motor weakness in neck and upper extremity. These symptoms appear at the dermatome and myotome distribution of the affected nerve root. Mostly the cervical radiculopathy is present unilaterally but in severe cases it can appear bilaterally where bony spurs are found at various levels and nerve root in under compression on both sides.
The annual incidence rate of cervical radiculopathy is reported to be 107.3 per 100,000 of men and 63.5 per 100,000 of women. So accordingly, the condition is more common in males than females.
Although no definitive treatment plan for cervical radiculopathy has been developed, there is a general consensus in the literature that using manual therapy techniques in conjunction with therapeutic exercise is effective in terms of increasing function and active range of motion (AROM). The focus will most likely be on reducing pain and disability. Recent researches have shown that exercise therapy has the highest beneficial outcomes.
Treatment options for rehabilitation plan includes: Education and advice, Manual Therapy - PAIVMs (Passive Accessory Intervertebral Movements) / PPIVMs (Passive Physiological Intervertebral Movements) / NAGs (Natural Apophyseal Glides) / SNAGs (Sustained Natural Apophyseal Glides),Exercise Therapy - AROM, stretching and strengthening and Postural re-education Cervical traction and electromyography (EMG) biofeedback have been administered by many physiotherapists and positive outcomes are revealed. Traction not only relives nerve root compression but also helps in managing acute pain instantly whereas EMG biofeedback is used to generate an electrical feedback signal in response to muscle activation and helps patients to learn a more effective way of using their weak muscles
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical traction with EMG biofeedback | Experimental | Other: cervical traction with EMG biofeedbackContinuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position. Ask the patient to assume sitting position on a comfortable chair. Place surface electrodes of EMG biofeedback at the level of C5-6 Para spinal muscles to pick up the activity of the muscles and convert it to vis-ual and auditory impulses produced from the device. Tell the patient to try to relax the tension of the neck muscles as much as he can by lowering the visual and auditory impulses from the device |
| cervical traction and conventional physical therapy | Active comparator | Other: cervical traction and conventional physical therapyContinuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Symptoms duration was more than one month up to six months.
- Radiculopathy due to muscle spasm.
- Radiculopathy due to postero-lateral disc herniation.
- Pain radiating with numbness and tingling sensations to both arms, forearms and hands.
Key exclusion criteria (6 listed)
- Patients diagnosed with thoracic outlet syndrome, diabetes mellitus, and/or carpel tunnel syndrome.
- Patients had severe sensory and/or motor manifestations.
- Patients had manifestations of central cervical disc herniation.
- Congenital conditions of the cervical spine.
- Patients with contraindications to mobilization techniques and those with dizziness due to vertebrobasilar insufficiency or vestibular dysfunctions.
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 |
|---|---|---|
| cervical traction with EMG biofeedbackContinuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position. Ask the patient to assume sitting position on a comfortable chair. Place surface electrodes of EMG biofeedback at the level of C5-6 Para spinal muscles to pick up the activity of the muscles and convert it to vis-ual and auditory impulses produced from the device. Tell the patient to try to relax the tension of the neck muscles as much as he can by lowering the visual and auditory impulses from the device | Other | cervical traction with EMG biofeedback |
| cervical traction and conventional physical therapyContinuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position | Other | cervical traction and conventional physical therapy |
Primary outcome
Visual Analogue Scale (VAS):
Time frame: for six weeks
It is a subjective tool used to measure intensity of pain. It starts from 0 meaning "No pain" to 10 meaning "Worst pain". The reliability and validity of VAS measured by ICC is 0.97 and 0.941 respectively.Assesment to be done on baseline,2nd week,4th week and 6th week.
Neck Disability Index (NDI)
Time frame: for six weeks
It is also a subjective tool used to evaluate neck disability. It ranks from 0 meaning "No pain" to 5 meaning "Worst imaginable pain". The reliability and validity if NDI measured by Cronbach's alpha is 0.89 and 0.60-0.70 respectively. Assessment to be done at baseline,2nd week,4th week and 6th week.
EMG biofeedback
Time frame: for six weeks
It is an electric device use to generate electrical feedback signals from activation of muscles. The reliability and validity of EMG biofeedback is 0.815-0.979 (19) and 0.781-0.907 respectively.Assesment to be done at baseline,2nd week,4th week and 6th week.
Inclinometer.
Time frame: for six weeks
Inclinometers have dials or digital readouts that display the angle at which the inclinometer is situated relative to the line of gravity. Inclinometer measurements of cervical flexion, extension, lateral flexion, and rotation were found to be reliable for all three methods with ICCs ranging from 0.89 to 0.94.Assesment to be done at baseline,2nd week,4th week and 6th 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 7 Sep 2022.
- Derived from this study: PubMed 42017707Sabir S, Khalid M, Khan KA, Qazi ZN, Obaid S, Khawar S. Effects of cervical traction with and without EMG biofeedback in patients with cervical radiculopathy- A randomised controlled trial. J Pak Med Assoc. 2026 Mar;76(3):308-315. doi: 10.47391/JPMA.21396.
- Individual participant dataSharing planned: No
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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, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical traction with EMG biofeedback and cervical traction and conventional physical therapy in people with Cervical Radiculopathy, run by Riphah International University at 1 site 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 4 inclusion and 6 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 7 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 1 site 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?
Visual Analogue Scale (VAS): (time frame: for six weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05352464, which also lists 1 linked publication.
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 7 Sep 2022.