Cervical RadiculopathyNCT03652831
Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy
A study testing Soft Tissue Mobilization with Neural Mobilization and Soft Tissue Mobilization without Neural Mobilization in people with Cervical Radiculopathy, run by Isra University.
Trial summary
This study will evaluate effect of soft tissue mobilization with and with out neural mobilization in cervical radiculopathy, half of the subjects will receive treatment of soft tissue mobilization along with neural mobilization whereas half of the subjects will receive only soft tissue mobilization. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Soft Tissue Mobilization with Neural Mobilization and Soft Tissue Mobilization without Neural Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Mar 2019
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with age 18 to 55years
- Patients having pain more than 3months
- Radiating pain in one of the upper limb
- Spurling's test positive
Who cannot join
- Traumatic injury of upper limb or cervical spine
- Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)
- Patient asymptomatic for pain but symptomatic for tingling and paraesthesia
- Circulatory disturbance of upper extremity
- Known history of high level of spinal cord injury and malignancy
- Thoracic Outlet syndrome
Trial locations and contacts
No sites are listed yet.
About this study
This study will evaluate effect of soft tissue mobilization with and with out neural mobilization in cervical radiculopathy, half of the subjects will receive treatment of soft tissue mobilization along with neural mobilization whereas half of the subjects will receive only soft tissue mobilization.
Read the detailed description
soft tissue mobilization and neural mobilization both treatments are used to treat cervical radiculopathy but they work differently.
Soft tissue mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance.
Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median. neural mobilization technique target the single nerve which is being compressed and showing symptoms.
- Conditions
- Cervical Radiculopathy
- Being tested
- Soft Tissue Mobilization with Neural Mobilization, Soft Tissue Mobilization without Neural Mobilization
- Keywords
- Cervical radiculopathy,, Soft tissue mobilization,, Neural mobilization
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Tissue Mobilization with Neural MobilizationOther
Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time.
- Hot Pack for 10mints
- Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minute.
- Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization.
Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session)
Soft Tissue Mobilization without Neural MobilizationOther
- Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time.
- Hot Pack for 10mints
- Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minutes Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session)
| Study group | Role | What they receive |
|---|---|---|
| Soft Tissues mobilization with Neural mobilization | Active comparator | Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques and Neural mobilization Techniques which involve Median, Radial and Ulnar Nerve Mobilization.
Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session) Receives: Other: Soft Tissue Mobilization with Neural Mobilization |
| Soft Tissues mobilization without Neural mobilization | Active comparator | Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques.
Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session) Receives: Other: Soft Tissue Mobilization without Neural Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity in one of the upper limb is measured by Numeric pain scale in which "0" shows No pain while "10" shows worst pain.
Measured: 4weeks
Secondary outcomes (2)
Recurrence of pain and Neck disability
Neck disability index scale used to measure ability to manage neck pain in everyday life in terms of: Pain intensity, Personal care, Lifting, Reading, Headaches, and Concentration. In which "0" shows disability and "5" shows normal.
Measured: 4weeks
Neck Range of Motion
Range of motion of the cervical spine and upper extremity (any of the upper limb) measured by Goniometer. Values deviated from standard values are considered as abnormal. The DASH Outcome Measure is scored as: the disability/symptom section (30 items, scored 1-5) where "1" shows No difficulty and "5" shows maximal difficulty
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionMar 2019 (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.
- 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
- Model description
- Subjects will be assigned randomly into two groups: Soft tissue mobilization with neural mobilization and Soft tissue mobilization without Neural mobilization.A coin will be flipped at start of data collection for the first patient to be assigned odd number and included in Soft tissue mobilization with Neural mobilization group. Later on odd and even numbered subjects will be included in specific group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Abid, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652831
- Sponsor's protocol ID
- IIRS-IUISB/Mphil/002
- Status last verified
- Aug 2018
- First submitted
- 27 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT03652831
- Acronym / sponsor ID
- IIRS-IUISB/Mphil/002
- Conditions
- Cervical Radiculopathy
- Keywords
- Cervical radiculopathy,, Soft tissue mobilization,, Neural mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 29 Aug 2018 (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.
This study will evaluate effect of soft tissue mobilization with and with out neural mobilization in cervical radiculopathy, half of the subjects will receive treatment of soft tissue mobilization along with neural mobilization whereas half of the subjects will receive only soft tissue mobilization.
Detailed description
soft tissue mobilization and neural mobilization both treatments are used to treat cervical radiculopathy but they work differently.
Soft tissue mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance.
Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median. neural mobilization technique target the single nerve which is being compressed and showing symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be assigned randomly into two groups: Soft tissue mobilization with neural mobilization and Soft tissue mobilization without Neural mobilization.A coin will be flipped at start of data collection for the first patient to be assigned odd number and included in Soft tissue mobilization with Neural mobilization group. Later on odd and even numbered subjects will be included in specific group.
| Arm | Type | Receives |
|---|---|---|
| Soft Tissues mobilization with Neural mobilization | Active comparator | Other: Soft Tissue Mobilization with Neural MobilizationSoft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques and Neural mobilization Techniques which involve Median, Radial and Ulnar Nerve Mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session) |
| Soft Tissues mobilization without Neural mobilization | Active comparator | Other: Soft Tissue Mobilization without Neural MobilizationSoft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with age 18 to 55years
- Patients having pain more than 3months
- Radiating pain in one of the upper limb
- Spurling's test positive
Key exclusion criteria (6 listed)
- Traumatic injury of upper limb or cervical spine
- Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)
- Patient asymptomatic for pain but symptomatic for tingling and paraesthesia
- Circulatory disturbance of upper extremity
- Known history of high level of spinal cord injury and malignancy
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 |
|---|---|---|
| Soft Tissue Mobilization with Neural MobilizationCervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time. * Hot Pack for 10mints * Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minute. * Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session) | Other | Soft Tissues mobilization with Neural mobilization |
| Soft Tissue Mobilization without Neural Mobilization* Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time. * Hot Pack for 10mints * Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minutes Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session) | Other | Soft Tissues mobilization without Neural mobilization |
Primary outcome
Pain intensity
Time frame: 4weeks
Pain intensity in one of the upper limb is measured by Numeric pain scale in which "0" shows No pain while "10" shows worst pain.
2 secondary outcomes
Recurrence of pain and Neck disability
Time frame: 4weeks
Neck Range of Motion
Time frame: 4weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Tissue Mobilization with Neural Mobilization and Soft Tissue Mobilization without Neural Mobilization in people with Cervical Radiculopathy, run by Isra University.
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: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Noor Ul Ain, Mphil-OPT (0333-5292822, Noorabid2015@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: 4weeks). 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 29 Aug 2018.