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Neural Mobilization With Intermittent Cervical Traction on Grip Strength, Sleep Quality, and Quality of Life in Cervical Radiculopathy

Primary Purpose

Cervical Radiculopathy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neural Mobilization with Intermittent Cervical Traction
Neural Mobilization
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Cervical Radiculopathy, Pain, Sleep Quality, Quality of Life, Grip Strength, Intermittent Cervical Traction, Neural Mobilization

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • The University of LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neural Mobilization with Intermittent Cervical Traction

Neural Mobilization

Arm Description

Patients in this experimental group will receive neural mobilization with intermittent cervical traction and routine physical therapy.

Patients in this control group will receive neural mobilization and routine physical therapy.

Outcomes

Primary Outcome Measures

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.
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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT06043934
Brief Title
Neural Mobilization With Intermittent Cervical Traction on Grip Strength, Sleep Quality, and Quality of Life in Cervical Radiculopathy
Official Title
Effects of Neural Mobilization With and Without Intermittent Cervical Traction on Grip Strength, Sleep Quality, and Quality of Life in Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Cervical Radiculopathy, Pain, Sleep Quality, Quality of Life, Grip Strength, Intermittent Cervical Traction, Neural Mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neural Mobilization with Intermittent Cervical Traction
Arm Type
Experimental
Arm Description
Patients in this experimental group will receive neural mobilization with intermittent cervical traction and routine physical therapy.
Arm Title
Neural Mobilization
Arm Type
Active Comparator
Arm Description
Patients in this control group will receive neural mobilization and routine physical therapy.
Intervention Type
Other
Intervention Name(s)
Neural Mobilization with Intermittent Cervical Traction
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Neural Mobilization
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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.
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.
Title
Status of Sleep Quality
Description
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.
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.
Title
Change in Quality of Life
Description
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.
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.
Title
Change in Grip Strength
Description
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
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabia Yaseen, MS
Phone
+923104334546
Email
rabiayaseen4059@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Jamil, M.Phil
Phone
+923244481031
Email
ayeshabutt031@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umair Ahmad, PhD
Organizational Affiliation
The University of Lahore
Official's Role
Study Director
Facility Information:
Facility Name
The University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
5400
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabia Yaseen, MS
Phone
+923104334546
Email
rabiayaseen4059@gmail.com
First Name & Middle Initial & Last Name & Degree
Ayesha Jamil, M.Phil
Phone
+923244481031
Email
ayesha.jamil@uipt.uol.edu.pk
First Name & Middle Initial & Last Name & Degree
Rabia Yaseen, MS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
After publication of manuscript.

Learn more about this trial

Neural Mobilization With Intermittent Cervical Traction on Grip Strength, Sleep Quality, and Quality of Life in Cervical Radiculopathy

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