Suboccipital Distraction vs. Manual Traction in Chronic Neck Pain

NCT06751758 | Completed

• 1 other identifier: Noor Fatima
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study addresses the pervasive issue of chronic neck pain, a debilitating condition with profound implications for daily life and well-being. Two therapeutic techniques, suboccipital distraction, and manual traction, are under investigation for their potential to alleviate upper cervical pain and enhance mobility in individuals suffering from chronic neck pain. The primary goal is to compare the effects of these interventions on upper cervical pain, range of motion, and functional disability, providing valuable insights for healthcare professionals to optimize treatment strategies and enhance outcomes in this challenging context. The research adopts a Randomized Clinical Trial (RCT) design to rigorously evaluate the impact of suboccipital distraction and manual traction on upper cervical pain, range of motion, and functional disability in chronic neck pain patients. The Gpower t-test sample size calculation ensures a robust sample size, enhancing statistical power and the validity of findings. Participants will be recruited from Neuro clinic, Lahore, using non-probability convenient sampling. The lottery method will be employed for randomizing participants into suboccipital distraction and manual traction groups, ensuring a balanced distribution of key characteristics. The diverse patient population at Neuro Clinic enhances the generalizability of the study's results. The treatment plan spans 4 weeks, comprising three sessions per week. Each session involves three sets of suboccipital distraction or manual traction, with 5 to 7 repetitions per set. Baseline assessments will be conducted, followed by post-treatment assessments at the 4-week mark. Outcome measures, including standardized pain scales, goniometry for range of motion, and validated instruments for functional disability, will be systematically collected during these intervals.

Conditions

Cervical Pain

Keywords

Cervical pain; Suboccipital Distraction; Manual Traction; Functional disability; Range of motion

Outcome Measures

Primary Outcomes (3)

• NPRS (Numerical Pain Rating Scale)

  The NPRS is a self-report measure used to assess the intensity of pain experienced by individuals. Participants rate their pain on a numerical scale from 0 (no pain) to 10 (worst possible pain). It is known for its simplicity and ease of administration, making it a practical tool in clinical and research settings. Psychometric Properties: Validity: Strong convergent validity demonstrated in studies such as Jensen et al. (1986), which compared NPRS with other established pain measures. Reliability: The NPRS has been shown to have good test-retest reliability, with consistent pain ratings over time. Usefulness: Widely used in clinical settings due to its solid psychometric properties, making it valuable for assessing pain intensity in various populations.

  baseline, after 4 weeks

• Goniometer

  The goniometer is a fundamental tool for objectively measuring joint range of motion (ROM). It consists of a protractor-like device that quantifies the angular displacement of a joint during movement. Validity and reliability of goniometric measurements are crucial to ensure accurate and consistent assessments. Previous research, such as the work by Norkin and White (2009), has supported the concurrent validity of goniometry by comparing its measurements with those obtained through radiographic imaging (25). The goniometer's well-established validity and reliability make it an indispensable tool for assessing joint mobility and tracking changes in range of motion over time.

  baseline, after 4 weeks

• NDI

  This will be used to measure function of neck.Neck disability index was the first tool to measure the self-reported disability in patients with neck pain. It has significant psychometric features and has been shown to be very responsible in clinical trials. The index has 10 neck-related functional activities scored on a 0-5 likert scale for each item and total score of 50. Higher score on the scale shows greater disability. The NDI has very good reliability (ICC = 0.88;\[0.63 to 0.95\]) (26, 27).

  baseline, after 4 weeks

Study Arms (2)

Group A - Suboccipital Distraction

EXPERIMENTAL

In addition to the initial conservative treatment phase (cervical spine mobilization targeting the C1-C2 region and a 20-minute session of Transcutaneous Electrical Nerve Stimulation (TENS)), participants in Group A will undergo suboccipital distraction as part of the subsequent intervention. Suboccipital distraction involves the gentle separation of the suboccipital muscles and associated structures to alleviate tension and promote relaxation. This technique specifically targets upper cervical pain and aims to enhance range of motion.

Other: C1-C2 Mobilization; Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Suboccipital Distraction

Group B - Traction

ACTIVE COMPARATOR

After the initial conservative treatment phase (cervical spine mobilization targeting the C1-C2 region and a 20-minute session of Transcutaneous Electrical Nerve Stimulation (TENS)), participants in Group B will receive traction as their intervention. Traction involves the application of controlled force to stretch and mobilize the cervical spine manually. The aim is to reduce compression on cervical structures, alleviate pain, and improve the range of motion.

Other: C1-C2 Mobilization; Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Traction

Interventions

C1-C2 Mobilization OTHER

Participants in both Group A and Group B will receive manual mobilization targeting the C1-C2 region. This specific mobilization technique is chosen for its potential to improve joint mobility and alleviate stiffness in the upper cervical spine. The mobilization will be performed by trained physiotherapists to ensure precision and safety.

Group A - Suboccipital Distraction; Group B - Traction

Transcutaneous Electrical Nerve Stimulation (TENS) OTHER

Following C1-C2 mobilization, each participant will undergo a 20-minute session of TENS. TENS involves the application of low-voltage electrical currents through electrodes placed on the skin. This modality aims to modulate pain perception by stimulating nerve fibers, leading to the release of endorphins - the body's natural painkillers. The 20-minute duration is chosen based on established guidelines for effective TENS application.

Group A - Suboccipital Distraction; Group B - Traction

Suboccipital Distraction OTHER

Suboccipital distraction is a manual technique aimed at relieving tension in the upper cervical spine. This intervention involves the gentle separation of the suboccipital muscles and associated structures, promoting relaxation and reducing pain. The technique is intended to enhance the range of motion in the cervical region by targeting the upper cervical structures. Procedure: 5-7 repetitions of intermittent distraction 20-30 seconds on, 10-15 seconds off Administration: Suboccipital distraction will be performed by skilled physiotherapists trained in this technique. Close monitoring will ensure correct application and participant safety.

Group A - Suboccipital Distraction

Traction OTHER

Traction is a therapeutic technique that involves applying a controlled, manual force to stretch and mobilize the cervical spine. The primary goal of this intervention is to reduce compression on the cervical structures, alleviate pain, and improve the range of motion. It is typically used for its potential to decompress the spine and relieve pressure on nerves. Procedure: Traction will be administered manually by trained physiotherapists, who will ensure that the correct amount of force is applied and that the treatment is both safe and effective. The application will be carefully tailored to the individual's needs. Administration: Participants will undergo traction treatments with close monitoring throughout the study period, allowing for necessary adjustments to the treatment plan based on individual responses.

Group B - Traction

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Minimum chronicity: of 3 months chronic neck pain (21)
• Spurling test (22)

You may not qualify if:

• Chronic systemic bony diseases
• Degenerative joint diseases
• Psychiatric diseases
• Recent history of trauma

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Neuro Clinic

Lahore, Punjab Province, 54782, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Traction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Noor Fatima, DPT

  Riphah International University, Lahore

  PRINCIPAL INVESTIGATOR

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: December 20, 2024
• First Posted: December 30, 2024
• Study Start: July 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)