EVALUATION OF THE EFFECT OF OSTEOPATHIC TREATMENT ON CHRONIC NONSPECIFIC NECK PAIN (Osteopathy)

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.

Study Overview

• Status: Completed
• Conditions: Nonspesific Neck Pain
• Intervention / Treatment: Procedure: Osteopathic treatment; Procedure: Standard Physical Therapy protocol

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Muğla, Turkey (Türkiye)
    • the Fiz-Em Healthy Life Counseling Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; Procedure: Standard Physical Therapy protocol; TENS therapy, infrared therapy, and exercise program.
Active Comparator: 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.	Procedure: Standard Physical Therapy protocol; TENS therapy, infrared therapy, and exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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

Collaborators and Investigators

• Sponsor: Istanbul Rumeli University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Physical therapy; disability; Manual Therapy; Osteopathic Manipulative Treatment; Nonspesific neck pain
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations; Manipulation, Osteopathic
• Other Study ID Numbers: E-53938333-050-45260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No