Clinical trial NCT04896749: Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy
Official title: Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: cervical radiculopathy
neuromobilization
pain
disability
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with trauma of upper limb and cervical spine
* Dizziness
* Upper limb circulatory disturbance
* Malignancy
* Patients with bilateral symptoms

Primary outcomes:
measure: Upper extremity functional index (assessing change in ability to do activities with upper limb at baseline and at 4th week of treatment)
timeFrame: Baseline and at 4th week
measure: Numeric pain rating scale (to assess change in pain at between baseline and at 4th week of treatment)
timeFrame: Baseline and at 4th week
measure: Neck Disability Index scale (to assess the change in disability due to neck pain at baseline and at 4th week of treatment)
timeFrame: Baseline and at 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University Physical Therapy and Rehabilitation Clinic
state: Punjab
Study officials:
affiliation: University of Lahore
name: Momna Asghar, MSPTN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lahore
name: Muhammad Haider Ullah Khan, MSPTN
role: STUDY_CHAIR
References: