Effect of Mechanical Traction in Patients With Chronic Neck Pain

Effect of Mechanical Traction on Functional Outcome and Sleep Quality in Patients With Chronic Neck Pain

This study will be conducted to investigate the effect of mechanical traction on pain, disability, cervical range of motion, sleep quality and insomnia in patients with chronic neck pain. Forty four female patients with chronic neck pain will participate in this study. The patients will be diagnosed as having chronic neck pain based on careful clinical examination by neurologist. Patients in this study will be randomly divided into two equal groups:

Group (A): Patients in this group will receive mechanical traction for 20 minutes in addition to conventional physical therapy.

Group (B): Patients in this group will receive conventional physical therapy only. The treatment will be conducted over six weeks, three days per week.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Device: mechanical traction; Device: conventional physical therapy

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female Patients with chronic neck pain.
• The age of patients will be ranged from 30-45 years old.
• Duration of pain will be more than six months.

Exclusion Criteria:

• Other neurological disorders causing sleep disorders as stroke and multiple sclerosis.
• Pregnancy.
• History of cervical spine surgery.
• Psychological disorders such as severe depression or anxiety.
• Active infection or malignancy in the cervical spine.
• Body mass index more than 30kg/m2.
• Diabetic or peripheral neuropathy.
• Severe myelopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (exprimental); Patients in this group will receive mechanical traction for 20 minutes in addition to conventional physical therapy. The treatment will be conducted over six weeks, three days per week.	Device: mechanical traction; Participants will be positioned in supine on a flat bed. A manual traction test will be performed to ensure that traction did not provoke any pain or unwanted sensations.The mechanical traction will be applied at 45° from the horizontal plane formed by the bed Mechanical traction was set to 5% of the participant's body weight on day 1 (unless not tolerated) and increased to reach 10% on the 5th day, as pain allowed, and without exceeding 12kg. Within a session, the load will applied progressively over 5 minutes and pain will be monitored using a VAS. The target weight will be then maintained for 20 minutes and then reduced gradually over the last 5 minutes. The patient then will lie still for 10 minutes before getting up Patients recieved conventional physical therapy treatment in addition to mechanical traction conducted over six weeks, three days per week.; Device: conventional physical therapy; Patients recieved conventional physical therapy which will include: 1-10 minute hot packs on the cervical and upper back. 2- Ultrasound: It will be applied to paraspinal muscles with a frequency of 1 MHz with a continuous mode and 0.5 W/Cm2 for 5 minutes using moving sound head technique. 3- Transcutaneous electrical nerve stimulation: The electrodes will be placed at the level of cervical paraspinal muscles and at the course of affected nerve. The impulse duration will be adjusted to 1ms with an interval of 5 ms. and frequency of 166 Hz for 20 minutes The treatment will be conducted over six weeks, three days per week.
Active Comparator: Group B(control); Patients in this group will receive conventional physical therapy only. The treatment will be conducted over six weeks, three days per week.	Device: conventional physical therapy; Patients recieved conventional physical therapy which will include: 1-10 minute hot packs on the cervical and upper back. 2- Ultrasound: It will be applied to paraspinal muscles with a frequency of 1 MHz with a continuous mode and 0.5 W/Cm2 for 5 minutes using moving sound head technique. 3- Transcutaneous electrical nerve stimulation: The electrodes will be placed at the level of cervical paraspinal muscles and at the course of affected nerve. The impulse duration will be adjusted to 1ms with an interval of 5 ms. and frequency of 166 Hz for 20 minutes The treatment will be conducted over six weeks, three days per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	The visual analog scale (VAS) is frequently used to measure pain intensity in patients with cervical spine disorders. The minimum clinically important difference (MCID) is the smallest change in a score that has clinical importance to the patient. Although it has been established for other medical fields, knowledge of the VAS MCID for the cervical spine is sparse, and it has rarely been considered in relation to measurement noise. the score represented in numbers from 0 to 10.	pre intervention and re assessed after 6 weeks of treatment
neck disability	neck disability index questionnaire was used to assess the disability caused by neck pain. The Neck disability index is a commonly used method to determine functional disability level of subjects with neck pain. it is a 10-item questionnaire used to measure self-reported disability related to neck pain, with higher scores indicating greater functional limitation, Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total raw score ranges from 0 to 50, which can be converted to a percentage by doubling the score, giving a range from 0% (no disability) to 100% (complete disability),	pre intervention and re assessed after 6 weeks of treatment
Cervical Range of Motion (CROM)	Cervical Range of Motion (CROM) device. The CROM device is a type of goniometer designed specifically for the cervical spine and was used to measure cervical ROM. It consists of a plastic frame that is mounted over the subject's nose bridge and ears and secured to the head by a felcro strap. Three independent inclinometers attached to the frame and arranged orthogonally to one another indicate the subject's cervical ROM. Cervical Range of Motion (CROM) is measured in angles	pre intervention and re assessed after 6 weeks of treatment
sleep quality	Pittsburg Sleep Quality Index (PSQI) is used to assess sleep quality. The Pittsburg sleep quality index is a self administered questionnaire used to assess sleep quality. It is considered the gold standard for evaluating sleep quality over a period of 1 month. It consists of 19 items and were calculated as the following 7 components: sleep latency, sleep duration, sleep quality, sleep disturbances, sleep efficiency, sleep medication, and daytime dysfunction. Each component of them was weighted equally and scored on a scale from 0-3 for a total score from 0-21. Its validity is confirmed by various studies in different populations of patients	pre intervention and re assessed after 6 weeks of treatment
Insomnia Severity	The Insomnia Severity Index (ISI) is used to assess insomnia. Itis a seven-question questionnaire that is given to the respondent to assess recent problems with falling asleep, maintaining sleep, early awakening and the consequences of insomnia, using five-level points (from 0-none to 4-very, a lot). The ISI score is obtained by summing the points for each item, and it ranges from 0 to 28. Higher scores correspond to insomnia of greater intensity, and can be classified into four categories: no insomnia (0-7), borderline insomnia (8-14), clinically clear insomnia-moderately severe (15-21) and clinically clear insomnia-severe (22-28)	pre intervention and re assessed after 6 weeks of treatment

Collaborators and Investigators

• Sponsor: Amira saad mohamed

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 012/006273

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No