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EVALUATION OF THE EFFECT OF OSTEOPATHIC TREATMENT ON CHRONIC NONSPECIFIC NECK PAIN

EVALUATION OF THE EFFECT OF OSTEOPATHIC TREATMENT ON CHRONIC NONSPECIFIC NECK PAIN

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07260422
Acronym
Osteopathy
Enrollment
40
Registered
2025-12-03
Start date
2024-11-12
Completion date
2025-06-01
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonspesific Neck Pain

Keywords

Osteopathic Manipulative Treatment, Nonspesific neck pain, Manual Therapy, disability, Physical therapy

Brief summary

This study evaluates whether adding osteopathic treatment to standard physical therapy improves outcomes in adults with nonspecific neck pain. Forty participants are randomly assigned to two groups: one group receives osteopathic techniques (myofascial release, trigger point therapy, craniosacral osteopathy, visceral osteopathy, osteopathic manipulation, and harmonic mobilization) in addition to standard physical therapy (TENS, infrared, and exercise), while the other group receives only standard physical therapy. All participants attend four weekly sessions. Pain, function, quality of life, muscle strength, and cervical range of motion are assessed before and after treatment. The outcomes assessor is blinded to group allocation. This study aims to determine whether osteopathic interventions provide additional benefits over standard physical therapy.

Interventions

This intervention includes a combination of osteopathic techniques, including myofascial release, trigger point therapy, craniosacral osteopathy, visceral osteopathy, osteopathic manipulation, and harmonic mobilization. Participants receive four weekly sessions, each lasting 45-60 minutes. This intervention is provided in addition to the standard physical therapy protocol.

PROCEDUREStandard Physical Therapy protocol

TENS therapy, infrared therapy, and exercise program.

Sponsors

Istanbul Rumeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes assessor was blinded to group allocation throughout all pre- and post-treatment evaluations. Participants and intervention providers were not blinded due to the nature of the treatments.

Intervention model description

This study uses a parallel-group, randomized design in which participants with nonspecific neck pain are assigned to one of two intervention arms. Both groups receive a standard physical therapy protocol, while the experimental group additionally receives a combination of osteopathic techniques, including myofascial release, trigger point therapy, craniosacral osteopathy, visceral osteopathy, osteopathic manipulation, and harmonic mobilization. All participants attend four weekly treatment sessions. Outcome assessments are conducted before the first session (baseline) and after the last session (post-intervention). These assessments include pain intensity (VAS), functional status (NDI), quality of life (SF-36), cervical muscle strength, and cervical range of motion. The outcomes assessor is blinded to group allocation to minimize assessment bias.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Individuals diagnosed with nonspecific neck pain for at least three months. * Pain of musculoskeletal origin. * Adults aged 18-65 years. * No analgesic medication taken within the previous 24 hours.

Exclusion criteria

* Neck pain due to trauma or injury. * Presence of osteoporosis or fracture risk. * Inflammatory or rheumatic diseases. * Presence of psychological disorders. * Any systemic disease affecting the musculoskeletal system. * Use of corticosteroid-containing medications. * Diagnosis of tumor or cancer. * Inability to complete the treatment process.

Design outcomes

Primary

MeasureTime frameDescription
Pain IntensityBaseline and immediately after 4 weekly treatment sessions (4 weeks total)Outcome Measure: Pain Intensity Time Frame: Baseline and after 4 weeks (post-intervention) Description: Change in pain level measured using the Visual Analog Scale (VAS) in participants with nonspecific neck pain. The Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst possible pain.

Secondary

MeasureTime frameDescription
Functional statusTime Frame: Baseline and after 4 weekly treatment sessions (4 weeks total)Functional Status Description: Change in functional status measured using the Neck Disability Index (NDI). The NDI consists of 10 items, each scored 0-5, with a total score ranging from 0 (no disability) to 50 (maximum disability). Scores can be converted to a percentage, with higher percentages indicating a greater degree of disability.
Life qualityBaseline and after 4 weekly treatment sessions (4 weeks total)Change in health-related quality of life measured using the SF-36 Quality of Life Scale.SF-36 consists of 36 items grouped into 8 domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Each domain is scored 0-100, with higher scores indicating better health status or quality of life.
Muscle strengthBaseline and after 4 weekly treatment sessions (4 weeks total)Change in cervical and shoulder muscle strength assessed using standardized manual muscle testing. Each muscle group is scored 0-5, where 0 = no contraction and 5 = normal strength against full resistance. Higher scores indicate stronger muscles.
Cervical Range of Motion (ROM)Baseline and after 4 weekly treatment sessionsChange in cervical spine range of motion measured using a goniometer. ROM is recorded in degrees for flexion, extension, lateral bending, and rotation. Higher values indicate greater mobility.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026