Suboccipital Distraction vs. Manual Traction in Chronic Neck Pain

NCT ID: NCT06751758

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-01-30

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.

Detailed Description

Chronic neck pain is a prevalent and debilitating condition affecting a substantial portion of the global population (1). Among the various therapeutic interventions, suboccipital distraction and manual traction emerge as two distinctive approaches, each holding promise in alleviating upper cervical pain, improving range of motion, and enhancing functional disability (2). The upper cervical region, comprising the atlas and axis vertebrae, plays a crucial role in supporting the head's weight and facilitating complex movements (3). Dysfunction in this area can lead to persistent pain and restricted mobility, warranting effective interventions for improved patient outcomes. This study aims to delve into the comparative effectiveness of suboccipital distraction versus manual traction, exploring their impact on upper cervical pain, range of motion, and functional disability in individuals suffering from chronic neck pain. Chronic neck pain is a multifaceted issue, often stemming from a combination of structural, biomechanical, and psychosocial factors (4). The upper cervical spine is particularly susceptible to dysfunction due to its intricate anatomy and constant engagement in supporting the head's movements. Suboccipital distraction, involving the gentle separation of the atlas and axis vertebrae, has gained attention as a therapeutic technique that targets specific structures in the upper cervical region. On the other hand, manual traction, characterized by the application of force to elongate the cervical spine, is another widely used intervention. Despite the prevalence of these approaches, there is a paucity of research directly comparing their efficacy in the context of chronic neck pain. Understanding the nuanced effects of suboccipital distraction and manual traction is crucial for optimizing treatment strategies and tailoring interventions to individual patient needs. Chronic neck pain is a multifaceted issue that affects a significant portion of the global population, with variations in prevalence across different regions. Studies conducted in Asia have reported a considerable number of individuals suffering from chronic neck pain. For instance, a survey in Japan found that approximately 23% of the population experienced persistent neck pain (5). In Europe, studies indicate varying prevalence rates, with a cross-European investigation estimating the prevalence to be around 15% (6). The situation in North America is also noteworthy, with a study conducted in the United States revealing that about 20% of the adult population reported chronic neck pain lasting more than three months (7). These regional disparities highlight the need for comprehensive research that considers diverse populations. Understanding the prevalence of chronic neck pain in different continents is crucial for contextualizing the importance of interventions such as suboccipital distraction and manual traction. Rationale for this study lies in the need for evidence-based guidance in selecting the most effective intervention for chronic neck pain, especially focusing on the upper cervical region. By comparing the outcomes of suboccipital distraction and manual traction, this research aims to contribute valuable insights into their respective impacts on pain reduction, range of motion improvement, and functional disability alleviation. Such knowledge is essential for clinicians seeking to provide personalized and efficient care to patients grappling with chronic neck pain. Moreover, the comparative effectiveness of these interventions can inform future treatment protocols, guiding healthcare professionals in making informed decisions based on empirical evidence. As the burden of chronic neck pain continues to rise globally, optimizing therapeutic approaches becomes imperative, and this study strives to bridge existing gaps in knowledge, paving the way for more effective and targeted interventions. The significance of this study is underscored by the potential implications for clinical practice and patient outcomes. With chronic neck pain being a widespread and often persistent condition, identifying the most effective intervention can substantially improve the quality of life for affected individuals. Suboccipital distraction and manual traction represent distinct therapeutic modalities, and a direct comparison will offer valuable insights into their relative efficacy.

Conditions

Cervical Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A - Suboccipital Distraction

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.

Group Type: EXPERIMENTAL

C1-C2 Mobilization

Intervention Type: 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.

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: 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.

Suboccipital Distraction

Intervention Type: 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 B - Traction

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.

Group Type: ACTIVE_COMPARATOR

C1-C2 Mobilization

Intervention Type: 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.

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: 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.

Traction

Intervention Type: 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.

Interventions

C1-C2 Mobilization

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.

Intervention Type: OTHER

Transcutaneous Electrical Nerve Stimulation (TENS)

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.

Intervention Type: OTHER

Suboccipital Distraction

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.

Intervention Type: OTHER

Traction

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noor Fatima, DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University, Lahore

Locations

Neuro Clinic

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Noor Fatima

Identifier Type: -

Identifier Source: org_study_id