Nonspesific Neck PainOsteopathyNCT07260422

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

A study testing Osteopathic treatment and Standard Physical Therapy protocol in people with Nonspesific Neck Pain, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Nonspesific Neck Pain
What is being tested?: Osteopathic treatment and Standard Physical Therapy protocol
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 12 Nov 2024to 1 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

the Fiz-Em Healthy Life Counseling Center
Muğla

Other trials in Turkey (Türkiye)

About this study

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
Being tested: Osteopathic treatment, Standard Physical Therapy protocol
Keywords: Osteopathic Manipulative Treatment, Nonspesific neck pain, Manual Therapy, disability, Physical therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Osteopathic treatmentProcedure or surgery
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 protocolProcedure or surgery
TENS therapy, infrared therapy, and exercise program.

Study groups in NCT07260422
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Standard Physical Therapy protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and immediately after 4 weekly treatment sessions (4 weeks total)

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 4 weekly treatment sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 20241 Jun 2025

First posted3 Dec 2025
Study start12 Nov 2024
Primary completion1 Mar 2025
Study completion1 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nonspesific Neck PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07260422
Sponsor's protocol ID: E-53938333-050-45260
Acronym: Osteopathy
Status last verified: Nov 2025
First submitted: 21 Nov 2025
Last updated: 3 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EVALUATION OF THE EFFECT OF OSTEOPATHIC TREATMENT ON CHRONIC NONSPECIFIC NECK PAIN
ClinicalTrials.gov ID: NCT07260422
Acronym / sponsor ID: Osteopathy / E-53938333-050-45260
Conditions: Nonspesific Neck Pain
Keywords: Osteopathic Manipulative Treatment, Nonspesific neck pain, Manual Therapy, disability, Physical therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Istanbul Rumeli UniversityUniversity, hospital or other
Study start: 12 Nov 2024 (actual)
Primary completion: 1 Mar 2025 (actual)
Study completion: 1 Jun 2025 (actual)
First posted: 3 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Osteopathic treatment and Physical Therapy	Experimental	Procedure: Osteopathic treatment, Procedure: Standard Physical Therapy protocolReceives 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.
Standard Physical Therapy Protocol	Active comparator	Procedure: Standard Physical Therapy protocolParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Osteopathic treatmentThis 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 or surgery	Osteopathic treatment and Physical Therapy
Standard Physical Therapy protocolTENS therapy, infrared therapy, and exercise program.	Procedure or surgery	Osteopathic treatment and Physical Therapy, Standard Physical Therapy Protocol

Primary outcome

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.

4 secondary outcomes

Functional status
Time frame: Time Frame: Baseline and after 4 weekly treatment sessions (4 weeks total)
Life quality
Time frame: Baseline and after 4 weekly treatment sessions (4 weeks total)
Muscle strength
Time frame: Baseline and after 4 weekly treatment sessions (4 weeks total)
Cervical Range of Motion (ROM)
Time frame: Baseline and after 4 weekly treatment sessions

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
Individual participant dataSharing planned: No. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathic treatment and Standard Physical Therapy protocol in people with Nonspesific Neck Pain, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Baseline and immediately after 4 weekly treatment sessions (4 weeks total)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07260422.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.