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

NCT06043934 | Unknown DMC

• 1 other identifier: REC-UOL-507-08-2023
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Radiculopathy

Keywords

Cervical Radiculopathy; Pain; Sleep Quality; Quality of Life; Grip Strength; Intermittent Cervical Traction; Neural Mobilization

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  Grip Strength will be measured at baseline, and change in grip strength will be measured at 2nd week and 4th week of treatment session.

Study Arms (2)

Neural Mobilization with Intermittent Cervical Traction

EXPERIMENTAL

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

Other: Neural Mobilization with Intermittent Cervical Traction

Neural Mobilization

ACTIVE COMPARATOR

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

Other: Neural Mobilization

Interventions

Neural Mobilization with Intermittent Cervical Traction OTHER

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 Mobilization with Intermittent Cervical Traction

Neural Mobilization OTHER

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).

Neural Mobilization

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• \. Injections in cervical spine in the past 2 weeks

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 5400, Pakistan

RECRUITING

MeSH Terms

Conditions

Radiculopathy; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Umair Ahmad, PhD

  University of Lahore

  STUDY DIRECTOR

Central Study Contacts

Rabia Yaseen, MS

CONTACT

+923104334546; rabiayaseen4059@gmail.com

Ayesha Jamil, M.Phil

CONTACT

+923244481031; ayeshabutt031@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: September 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 15, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of manuscript.

Locations

PA (1)