Cervical RadiculopathyNCT06043934
Neural Mobilization With Intermittent Cervical Traction on Grip Strength, Sleep Quality, and Quality of Life in Cervical Radiculopathy
A study testing Neural Mobilization with Intermittent Cervical Traction and Neural Mobilization in people with Cervical Radiculopathy, run by University of Lahore at 1 site in Pakistan.
Trial summary
Cervical radiculopathy commonly called "pinched nerve," occurs when a nerve in the neck is compressed or irritated where it branches away from the spinal cord. This may cause pain that radiates into the shoulder and/or arm, as well as muscle weakness and numbness. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Neural Mobilization with Intermittent Cervical Traction and Neural Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 15 Jan 2024
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects of any gender
- Age between 35 and 55 years
- Experience of unilateral upper-extremity pain, numbness, or paranesthesia. This must include a history of neck pain associated with radicular pain below the occiput and on one side of the neck, along with a tingling sensation on the lateral aspect of the elbow joint.
- Positive results in at least three out of four tests Spurling's test, Distraction test, Upper Limb Neurodynamic Test 1, and ipsilateral cervical rotation of less than 60°, according to a clinical prediction rule.
Who cannot join
- History of previous cervical or thoracic spine surgery
- Bilateral upper-extremity symptoms
- Signs or symptoms of upper motor neuron disease
- Medical "red flags" (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
- 4. Injections in cervical spine in the past 2 weeks
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
The University of Lahore
Lahore, Punjab Province, 5400
Rabia Yaseen, MS, +923104334546, rabiayaseen4059@gmail.com
Ayesha Jamil, M.Phil, +923244481031, ayesha.jamil@uipt.uol.edu.pk
About this study
Official title: Effects of Neural Mobilization With and Without Intermittent Cervical Traction on Grip Strength, Sleep Quality, and Quality of Life in Cervical Radiculopathy
Cervical radiculopathy commonly called "pinched nerve," occurs when a nerve in the neck is compressed or irritated where it branches away from the spinal cord. This may cause pain that radiates into the shoulder and/or arm, as well as muscle weakness and numbness.
Read the detailed description
Cervical radiculopathy (CR) is a disorder of the peripheral nervous system that affects the normal function of the cervical nerve roots (CNRs). It is frequently linked to chronic pain and daily functional limitations. The goal of the neural tissue mobilization technique is to restore the nervous system's capacity to tolerate the normal compressive, tensile, and frictional forces that are associated with day-to-day activities and to examine the neural tension in nerves and mobilize the nerves that exhibit neural tension through passive and active movements using tensioning and gliding. Cervical traction reduces pressure within the vertebral disks and unloads the structures of the spine by stretching muscles and ligaments. They are clinically important techniques that are easily understood by patients.
- Conditions
- Cervical Radiculopathy
- Being tested
- Neural Mobilization with Intermittent Cervical Traction, Neural Mobilization
- Keywords
- Cervical Radiculopathy, Pain, Sleep Quality, Quality of Life, Grip Strength, Intermittent Cervical Traction, Neural Mobilization
- Medical subject headings
- Radiculopathy, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Mobilization with Intermittent Cervical TractionOther
This group will receive Neural Mobilization with Intermittent Cervical Traction along with routine physical therapy. The patient will be positioned in a supine position with 10 to 15 degrees of flexion on a comfortable treatment table. A suitable pillow will be arranged to support their head. The cervical traction device's integrity and readiness will be confirmed by the therapist. The starting weight will be about 10% of the patient's body weight, and this will slowly increase up to an appropriate level. The on-and-off times will be decided based on the patient's comfort and specific condition. Generally, a ratio of 3:1 or 4:1 (hold: rest) is used. For instance, 60 seconds of traction followed by 20 seconds of rest. The total treatment time will generally range between 15-20 minutes for 3 to 4 times per week. Participants will be scheduled to attend 12 treatment sessions ( 3-4 sessions every week for 4 weeks; 45 min each session).
Neural MobilizationOther
This Group will receive Neural Mobilization with routine physical therapy. Each nerve glide exercise will be performed ideally around 2-3 times, depending on the patient's comfort and tolerance levels. The intensity of the exercise is governed by the degree of stretch applied to the nerve. This should be within the patient's comfort level, causing a mild stretching sensation rather than pain. Each nerve glide will be performed in a set of 10-15 repetitions. Rest periods should be provided between each repetition and set, ensuring the patient's comfort.
In median nerve glide the patient will be seated comfortably. Their arm will be guided into shoulder depression, elbow extension, forearm supination, and wrist and finger extension. The patient will then be instructed to slowly flex and extend their wrist while maintaining the other positions. Participants will be scheduled to attend 12 treatment sessions ( 3-4 sessions every week for 4 weeks; 45 min each session).
| Study group | Role | What they receive |
|---|---|---|
| Neural Mobilization with Intermittent Cervical Traction | Experimental | Patients in this experimental group will receive neural mobilization with intermittent cervical traction and routine physical therapy. Receives: Other: Neural Mobilization with Intermittent Cervical Traction |
| Neural Mobilization | Active comparator | Patients in this control group will receive neural mobilization and routine physical therapy. Receives: Other: Neural Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity is assessed using the Visual Analogue Scale (VAS), a unidimensional measure of pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain), with the patient asked to rate their current level of pain.
Measured: Pain intensity will be measured at baseline, and change in pain intensity will be measured at 2nd week and 4th week of treatment session.
Status of Sleep Quality
Sleep quality is evaluated using the Chronic Pain Sleep Inventory (CPSI), a self- administered, a multidimensional questionnaire that assesses sleep disturbances related to chronic pain. Patients report their sleep-related difficulties on a scale of 0 to 100, where 0 represents never having sleep disturbances and 100 represents always having sleep disturbances.
Measured: Sleep quality will be measured at baseline, and change in sleep quality status will be measured at 2nd week and 4th week of treatment session.
Change in Quality of Life
Quality of Life (QOL) is assessed using the SF-36 questionnaire, a standard, validated instrument for measuring health-related quality of life. The SF-36 covers eight health domains: physical function, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Its score ranges from 0 to 100 with 0 representing poor quality of life and 100 representing good quality of life.
Measured: Quality of life will be measured at baseline, and change in quality of life will be measured at 2nd week and 4th week of treatment session.
Change in Grip Strength
Grip strength is evaluated using an isometric dynamometer, a device designed to assess the maximum isometric strength of the hand and forearm muscles. Grip strength for males range from 40 to 64 kg and for females from 20 to 38 kg
Measured: Grip Strength will be measured at baseline, and change in grip strength will be measured at 2nd week and 4th week of treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
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.
- More trials run by University of LahoreThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Umair Ahmad, PhD, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043934
- Sponsor's protocol ID
- REC-UOL-507-08-2023
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neural Mobilization With and Without Intermittent Cervical Traction on Grip Strength, Sleep Quality, and Quality of Life in Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT06043934
- Acronym / sponsor ID
- REC-UOL-507-08-2023
- Conditions
- Cervical Radiculopathy
- Keywords
- Cervical Radiculopathy, Pain, Sleep Quality, Quality of Life, Grip Strength, Intermittent Cervical Traction, Neural Mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 21 Sep 2023 (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 commonly called "pinched nerve," occurs when a nerve in the neck is compressed or irritated where it branches away from the spinal cord. This may cause pain that radiates into the shoulder and/or arm, as well as muscle weakness and numbness.
Detailed description
Cervical radiculopathy (CR) is a disorder of the peripheral nervous system that affects the normal function of the cervical nerve roots (CNRs). It is frequently linked to chronic pain and daily functional limitations. The goal of the neural tissue mobilization technique is to restore the nervous system's capacity to tolerate the normal compressive, tensile, and frictional forces that are associated with day-to-day activities and to examine the neural tension in nerves and mobilize the nerves that exhibit neural tension through passive and active movements using tensioning and gliding. Cervical traction reduces pressure within the vertebral disks and unloads the structures of the spine by stretching muscles and ligaments. They are clinically important techniques that are easily understood by patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural Mobilization with Intermittent Cervical Traction | Experimental | Other: Neural Mobilization with Intermittent Cervical TractionPatients in this experimental group will receive neural mobilization with intermittent cervical traction and routine physical therapy. |
| Neural Mobilization | Active comparator | Other: Neural MobilizationPatients in this control group will receive neural mobilization and routine physical therapy. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects of any gender
- Age between 35 and 55 years
- Experience of unilateral upper-extremity pain, numbness, or paranesthesia. This must include a history of neck pain associated with radicular pain below the occiput and on one side of the neck, along with a tingling sensation on the lateral aspect of the elbow joint.
- Positive results in at least three out of four tests Spurling's test, Distraction test, Upper Limb Neurodynamic Test 1, and ipsilateral cervical rotation of less than 60°, according to a clinical prediction rule.
Key exclusion criteria (5 listed)
- History of previous cervical or thoracic spine surgery
- Bilateral upper-extremity symptoms
- Signs or symptoms of upper motor neuron disease
- Medical "red flags" (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
- 4. Injections in cervical spine in the past 2 weeks
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 |
|---|---|---|
| Neural Mobilization with Intermittent Cervical TractionThis group will receive Neural Mobilization with Intermittent Cervical Traction along with routine physical therapy. The patient will be positioned in a supine position with 10 to 15 degrees of flexion on a comfortable treatment table. A suitable pillow will be arranged to support their head. The cervical traction device's integrity and readiness will be confirmed by the therapist. The starting weight will be about 10% of the patient's body weight, and this will slowly increase up to an appropriate level. The on-and-off times will be decided based on the patient's comfort and specific condition. Generally, a ratio of 3:1 or 4:1 (hold: rest) is used. For instance, 60 seconds of traction followed by 20 seconds of rest. The total treatment time will generally range between 15-20 minutes for 3 to 4 times per week. Participants will be scheduled to attend 12 treatment sessions ( 3-4 sessions every week for 4 weeks; 45 min each session). | Other | Neural Mobilization with Intermittent Cervical Traction |
| Neural MobilizationThis Group will receive Neural Mobilization with routine physical therapy. Each nerve glide exercise will be performed ideally around 2-3 times, depending on the patient's comfort and tolerance levels. The intensity of the exercise is governed by the degree of stretch applied to the nerve. This should be within the patient's comfort level, causing a mild stretching sensation rather than pain. Each nerve glide will be performed in a set of 10-15 repetitions. Rest periods should be provided between each repetition and set, ensuring the patient's comfort. In median nerve glide the patient will be seated comfortably. Their arm will be guided into shoulder depression, elbow extension, forearm supination, and wrist and finger extension. The patient will then be instructed to slowly flex and extend their wrist while maintaining the other positions. Participants will be scheduled to attend 12 treatment sessions ( 3-4 sessions every week for 4 weeks; 45 min each session). | Other | Neural Mobilization |
Primary outcome
Pain Intensity
Time frame: Pain intensity will be measured at baseline, and change in pain intensity will be measured at 2nd week and 4th week of treatment session.
Pain intensity is assessed using the Visual Analogue Scale (VAS), a unidimensional measure of pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain), with the patient asked to rate their current level of pain.
Status of Sleep Quality
Time frame: Sleep quality will be measured at baseline, and change in sleep quality status will be measured at 2nd week and 4th week of treatment session.
Sleep quality is evaluated using the Chronic Pain Sleep Inventory (CPSI), a self- administered, a multidimensional questionnaire that assesses sleep disturbances related to chronic pain. Patients report their sleep-related difficulties on a scale of 0 to 100, where 0 represents never having sleep disturbances and 100 represents always having sleep disturbances.
Change in Quality of Life
Time frame: Quality of life will be measured at baseline, and change in quality of life will be measured at 2nd week and 4th week of treatment session.
Quality of Life (QOL) is assessed using the SF-36 questionnaire, a standard, validated instrument for measuring health-related quality of life. The SF-36 covers eight health domains: physical function, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Its score ranges from 0 to 100 with 0 representing poor quality of life and 100 representing good quality of life.
Change in Grip Strength
Time frame: Grip Strength will be measured at baseline, and change in grip strength will be measured at 2nd week and 4th week of treatment session.
Grip strength is evaluated using an isometric dynamometer, a device designed to assess the maximum isometric strength of the hand and forearm muscles. Grip strength for males range from 40 to 64 kg and for females from 20 to 38 kg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Yes
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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.
Umair Ahmad, PhD study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Mobilization with Intermittent Cervical Traction and Neural Mobilization in people with Cervical Radiculopathy, run by University of Lahore 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 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabia Yaseen, MS (+923104334546, rabiayaseen4059@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Pain intensity will be measured at baseline, and change in pain intensity will be measured at 2nd week and 4th week of treatment session.). 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?
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 21 Sep 2023.