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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteopathic treatment and Physical Therapy | Experimental | Receives a combination of osteopathic techniques (myofascial release, trigger point therapy, craniosacral osteopathy, visceral osteopathy, osteopathic manipulation, and harmonic mobilization) in addition to the standard physical therapy protocol (TENS therapy, infrared therapy, and exercise program). Participants received 4 sessions of treatment, once a week. |
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| Standard Physical Therapy Protocol | Active Comparator | Participants in this group receive only the standard physical therapy protocol, which includes TENS therapy, infrared therapy, and an exercise program. All participants attend four weekly treatment sessions. Outcome assessments, including pain (VAS), function (NDI), quality of life (SF-36), muscle strength, and cervical range of motion, are conducted before and after the intervention period. The outcomes assessor is blinded to group allocation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | 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. | Baseline and immediately after 4 weekly treatment sessions (4 weeks total) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status | 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. | Time Frame: Baseline and after 4 weekly treatment sessions (4 weeks total) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Fiz-Em Healthy Life Counseling Center | Muğla | Turkey (Türkiye) |
Individual participant data (IPD) from this study will not be shared because the dataset contains sensitive patient health information, and participants did not provide consent for public data sharing.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2024 | Nov 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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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.
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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.
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| Standard Physical Therapy protocol | Procedure | TENS therapy, infrared therapy, and exercise program. |
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| Life quality | 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. | Baseline and after 4 weekly treatment sessions (4 weeks total) |
| Muscle strength | 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. | Baseline and after 4 weekly treatment sessions (4 weeks total) |
| Cervical Range of Motion (ROM) | Change 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. | Baseline and after 4 weekly treatment sessions |
| D012046 | Rehabilitation |