Cervical RadiculopathyNCT04896749
Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy
A study testing Nerve mobilization and Conventional physical therapy in people with Cervical Radiculopathy, run by University of Lahore at 1 site in Pakistan.
Trial summary
Objective of the study is to find out the effectiveness of nerve mobilization in patients with cervical radiculopathy. It is a single blinded randomized controlled trial using non-probability convenient sampling. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Nerve mobilization and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2021to 16 Aug 2021
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients with age between 20 to 45 years
- Patients having pain for more than 4 months
- Patients having positive upper limb neurodynamic test
- Patient with positive spurling test.
Who cannot join
- Patients with trauma of upper limb and cervical spine
- Dizziness
- Upper limb circulatory disturbance
- Malignancy
- Patients with bilateral symptoms
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University Physical Therapy and Rehabilitation Clinic
Lahore, Punjab Province, 54000
About this study
Official title: Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy: A Randomized Controlled Trial
Objective of the study is to find out the effectiveness of nerve mobilization in patients with cervical radiculopathy. It is a single blinded randomized controlled trial using non-probability convenient sampling. Data is collected from University Physical therapy and Rehabilitation Clinic, University of Lahore, Pakistan.
Alternate hypothesis: There is a significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy.
Null hypothesis: There is no significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy.
.
Read the detailed description
It will be a prospectively registered, parallel designed, randomized controlled trial with concealed allocation, conducted in University Physical Therapy and Rehabilitation Clinic, Lahore, Pakistan. Patients who met the eligibility criteria will be informed about the aim of the study. All eligible participants who will agree to participate in the study signed the consent form. Eligibility of the participants will be determined by the two members of the research team before the randomization. After baseline assessment, eligible patients will be randomly assigned (in a 1:1 ratio) into two groups (Group A and Group B). Randomization will be done by one of the research team members using fish bowl method. Randomization assignments will be kept in opaque, sealed envelopes and unsealed by the researchers after baseline testing. Outcome assessor will be masked to group allocation and patients will be instructed not to talk about the content of their exercise program during the post intervention visit and could contact their therapists in case of any problems during trial participation. Help of female physiotherapist will be taken for the female patients. The sample size was calculated as 76 participants (38 per group), allowing statistical power of 80%, an alpha level of 5% and attrition rate of 20% having mean difference of 1.1 and SD of 1.48 and 1.63.
- Conditions
- Cervical Radiculopathy
- Being tested
- Nerve mobilization, Conventional physical therapy
- Keywords
- cervical radiculopathy, neuromobilization, pain, 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.
Nerve mobilizationOther
Moist pack all over cervical spine for 10 minutes. TENS for 10 minutes at frequency of 60 Hz with 2 electrodes. Cervical traction for 10 minutes with 7 sec hold and 5 sec rest time. Cervical isometric exercises with 7 sec hold and 30 repetitions in each direction twice a day.
Median, ulnar and radial nerve stretch with 3 sets of 10 repetitions , with 3 sec hold at final stretched position.
Following nerve mobilizations are used in experimental group/group A:
Median Nerve: Glenohumeral abduction, wrist extension, supination, glenohumeral lateral rotation, elbow extension, neck lateral bending to opposite side. Radial Nerve: Glenohumeral depression, elbow extension, whole arm internal rotation, wrist flexion Ulnar Nerve: Wrist extension, forearm pronation elbow flexion, glenohumeral lateral rotation, glenohumeral depression, shoulder abduction each with 3 sets of 10 repetitions , with 3 sec hold at final stretched position.
Conventional physical therapyOther
Also called Routine physical therapy
Moist pack for 10 minutes. TENS for 10 minutes at frequency of 60 Hz with 2 electrodes. Cervical traction for 10 minutes with 7 sec hold and 5 sec rest time. Cervical isometric exercises with 7 sec hold and 30 repetitions in each direction twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Group A/ Nerve mobilization group | Experimental | In this group, patients will receive nerve mobilization exercises along with routine physical therapy. Patients will also be given home plan for cervical isometric exercises. Receives: Other: Nerve mobilization |
| Group B/ Conventional physical therapy group | Active comparator | In this group, patients will receive routine physical therapy and also given home plan for cervical isometric exercises Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity functional index (assessing change in ability to do activities with upper limb at baseline and at 4th week of treatment)
It is a patient reported outcome measure used to assess the functional impairment in individuals with upper limb dysfunction. Total score is 80. Greater the score, better the condition of patients.
Measured: Baseline and at 4th week
Numeric pain rating scale (to assess change in pain at between baseline and at 4th week of treatment)
Used for scoring pain level of individual. it is scored 0 to ten.Zero being the lowest pain level, 10 being worst pain level.The patient is asked to make three pain ratings, corresponding to the pain experienced over the past 24 hours.
The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.
Measured: Baseline and at 4th week
Neck Disability Index scale (to assess the change in disability due to neck pain at baseline and at 4th week of treatment)
This scale is used for accessing how the neck pain is affecting the ability to manage everyday life activities.The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points of total 10 questions are summed to a total score.Greater score indicates greater disability.
Measured: Baseline and at 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Jun 2021
- Primary completion13 Aug 2021
- Study completion16 Aug 2021
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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momna Asghar, University of Lahore
- Investigators
- Momna Asghar, MSPTN, Principal investigator, University of LahoreMuhammad Haider Ullah Khan, MSPTN, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896749
- Sponsor's protocol ID
- IRB-UOL-FAHS/719-VI/2020
- Status last verified
- Nov 2021
- First submitted
- 8 Apr 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information will be shared if needed for betterment and further clinical studies, however the patient's name and personal information will be kept hidden
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04896749
- Acronym / sponsor ID
- IRB-UOL-FAHS/719-VI/2020
- Conditions
- Cervical Radiculopathy
- Keywords
- cervical radiculopathy, neuromobilization, pain, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 21 May 2021 (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.
Objective of the study is to find out the effectiveness of nerve mobilization in patients with cervical radiculopathy. It is a single blinded randomized controlled trial using non-probability convenient sampling. Data is collected from University Physical therapy and Rehabilitation Clinic, University of Lahore, Pakistan.
Alternate hypothesis: There is a significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy.
Null hypothesis: There is no significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy.
.
Detailed description
It will be a prospectively registered, parallel designed, randomized controlled trial with concealed allocation, conducted in University Physical Therapy and Rehabilitation Clinic, Lahore, Pakistan. Patients who met the eligibility criteria will be informed about the aim of the study. All eligible participants who will agree to participate in the study signed the consent form. Eligibility of the participants will be determined by the two members of the research team before the randomization. After baseline assessment, eligible patients will be randomly assigned (in a 1:1 ratio) into two groups (Group A and Group B). Randomization will be done by one of the research team members using fish bowl method. Randomization assignments will be kept in opaque, sealed envelopes and unsealed by the researchers after baseline testing. Outcome assessor will be masked to group allocation and patients will be instructed not to talk about the content of their exercise program during the post intervention visit and could contact their therapists in case of any problems during trial participation. Help of female physiotherapist will be taken for the female patients. The sample size was calculated as 76 participants (38 per group), allowing statistical power of 80%, an alpha level of 5% and attrition rate of 20% having mean difference of 1.1 and SD of 1.48 and 1.63.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A/ Nerve mobilization group | Experimental | Other: Nerve mobilizationIn this group, patients will receive nerve mobilization exercises along with routine physical therapy. Patients will also be given home plan for cervical isometric exercises. |
| Group B/ Conventional physical therapy group | Active comparator | Other: Conventional physical therapyIn this group, patients will receive routine physical therapy and also given home plan for cervical isometric exercises |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female patients with age between 20 to 45 years
- Patients having pain for more than 4 months
- Patients having positive upper limb neurodynamic test
- Patient with positive spurling test.
Key exclusion criteria (5 listed)
- Patients with trauma of upper limb and cervical spine
- Dizziness
- Upper limb circulatory disturbance
- Malignancy
- Patients with bilateral symptoms
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 |
|---|---|---|
| Nerve mobilizationMoist pack all over cervical spine for 10 minutes. TENS for 10 minutes at frequency of 60 Hz with 2 electrodes. Cervical traction for 10 minutes with 7 sec hold and 5 sec rest time. Cervical isometric exercises with 7 sec hold and 30 repetitions in each direction twice a day. Median, ulnar and radial nerve stretch with 3 sets of 10 repetitions , with 3 sec hold at final stretched position. Following nerve mobilizations are used in experimental group/group A: Median Nerve: Glenohumeral abduction, wrist extension, supination, glenohumeral lateral rotation, elbow extension, neck lateral bending to opposite side. Radial Nerve: Glenohumeral depression, elbow extension, whole arm internal rotation, wrist flexion Ulnar Nerve: Wrist extension, forearm pronation elbow flexion, glenohumeral lateral rotation, glenohumeral depression, shoulder abduction each with 3 sets of 10 repetitions , with 3 sec hold at final stretched position. | Other | Group A/ Nerve mobilization group |
| Conventional physical therapyAlso: Routine physical therapyMoist pack for 10 minutes. TENS for 10 minutes at frequency of 60 Hz with 2 electrodes. Cervical traction for 10 minutes with 7 sec hold and 5 sec rest time. Cervical isometric exercises with 7 sec hold and 30 repetitions in each direction twice a day. | Other | Group B/ Conventional physical therapy group |
Primary outcome
Upper extremity functional index (assessing change in ability to do activities with upper limb at baseline and at 4th week of treatment)
Time frame: Baseline and at 4th week
It is a patient reported outcome measure used to assess the functional impairment in individuals with upper limb dysfunction. Total score is 80. Greater the score, better the condition of patients.
Numeric pain rating scale (to assess change in pain at between baseline and at 4th week of treatment)
Time frame: Baseline and at 4th week
Used for scoring pain level of individual. it is scored 0 to ten.Zero being the lowest pain level, 10 being worst pain level.The patient is asked to make three pain ratings, corresponding to the pain experienced over the past 24 hours. The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.
Neck Disability Index scale (to assess the change in disability due to neck pain at baseline and at 4th week of treatment)
Time frame: Baseline and at 4th week
This scale is used for accessing how the neck pain is affecting the ability to manage everyday life activities.The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points of total 10 questions are summed to a total score.Greater score indicates greater disability.
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 30 Nov 2021.
- Individual participant dataSharing planned: Yes. Information will be shared if needed for betterment and further clinical studies, however the patient's name and personal information will be kept hidden
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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.
Momna Asghar, MSPTN principal investigator
University of Lahore
Muhammad Haider Ullah Khan, MSPTN study chair
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 Nerve mobilization and Conventional physical therapy 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: finished, as of the sponsor's last update on 30 Nov 2021. 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?
Upper extremity functional index (assessing change in ability to do activities with upper limb at baseline and at 4th week of treatment) (time frame: Baseline and at 4th week). 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 30 Nov 2021.