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

NCT07260422 | Completed

• 1 other identifier: E-53938333-050-45260
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonspesific Neck Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional status

  Time Frame: Baseline and after 4 weekly treatment sessions (4 weeks total)

• Life quality

  Baseline and after 4 weekly treatment sessions (4 weeks total)

• Muscle strength

  Baseline and after 4 weekly treatment sessions (4 weeks total)

• Cervical Range of Motion (ROM)

  Baseline and after 4 weekly treatment sessions

Study Arms (2)

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.

Procedure: Osteopathic treatment; Procedure: Standard Physical Therapy protocol

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.

Procedure: Standard Physical Therapy protocol

Interventions

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.

Osteopathic treatment and Physical Therapy

Standard Physical Therapy protocol PROCEDURE

TENS therapy, infrared therapy, and exercise program.

Osteopathic treatment and Physical Therapy; Standard Physical Therapy Protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Rumeli University: lead

Study Sites (1)

the Fiz-Em Healthy Life Counseling Center

Muğla, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: November 12, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)