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

NCT ID: NCT07260422

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Nonspesific Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Osteopathic treatment and Physical Therapy

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.

Group Type EXPERIMENTAL

Osteopathic treatment

Intervention Type 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.

Standard Physical Therapy protocol

Intervention Type PROCEDURE

TENS therapy, infrared therapy, and exercise program.

Standard Physical Therapy Protocol

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.

Group Type ACTIVE_COMPARATOR

Standard Physical Therapy protocol

Intervention Type PROCEDURE

TENS therapy, infrared therapy, and exercise program.

Interventions

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Osteopathic treatment

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.

Intervention Type PROCEDURE

Standard Physical Therapy protocol

TENS therapy, infrared therapy, and exercise program.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Rumeli University

OTHER

Sponsor Role lead

Responsible Party

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Ozden Baskan

Assist.Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Fiz-Em Healthy Life Counseling Center

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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E-53938333-050-45260

Identifier Type: -

Identifier Source: org_study_id

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