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OpenTrials
Completed

NCT Number: NCT07260422

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

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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Key information

Conditions

Nonspesific Neck Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Fiz-Em Healthy Life Counseling Center

Muğla, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard Physical Therapy protocol

Procedure

TENS therapy, infrared therapy, and exercise program.

Primary outcomes

  1. Pain Intensity

    Time frame: Baseline 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 outcomes

  1. Functional status

    Time frame: Time 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.

  2. Life quality

    Time frame: Baseline 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.

  3. Muscle strength

    Time frame: Baseline 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.

  4. Cervical Range of Motion (ROM)

    Time frame: Baseline and after 4 weekly treatment sessions

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Rumeli University

Other

Registry information

Acronym: Osteopathy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.