- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07729722
Comparison of Chiropractic and Physiotherapy in Chronic Neck Pain (KFA-KT)
Comparison of Conventional Physiotherapy and Conventional Physiotherapy Combined With Chiropractic in Patients With Non-Specific Neck Pain
Chronic neck pain will be a common condition that can negatively affect daily activities, mobility, and overall quality of life. This study will aim to investigate whether adding chiropractic treatment to standard physiotherapy will improve outcomes in individuals with long-standing neck pain.
A total of 40 adults between the ages of 20 and 65 with complaints of neck pain will be included in the study. Participants will be randomly assigned to two groups. One group will receive chiropractic treatment in addition to standard physiotherapy, while the other group will receive only standard physiotherapy. Standard physiotherapy will include TENS, heat therapy, and neck massage.
The treatments will be administered over a total of 7 sessions, twice a week. Before and after the treatment period, all participants will undergo a series of assessments. These will measure pain levels, neck function, muscle strength, range of motion, and quality of life.
The aim of this study will be to determine whether adding chiropractic treatment to physiotherapy will provide additional benefits in reducing pain and improving function and quality of life in individuals with chronic neck pain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Apex Medical Surgery Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 18-65 years of age
- Having neck pain that has lasted for least three months
- Having a Visual Analog Scale (VAS) score of at least 3
Exclusion Criteria:
- Patients not aged 18-60 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: physiotherapy
The group received 20 minutes of TENS and 20 minutes of hotpack therapy.
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A 20-minute TENS session and a 20-minute hot pack application will be applied twice a week for 7 weeks
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Active Comparator: Physiotherapy + Chiropractic Treatment
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The group will receive a 20-minute TENS session and a 20-minute hot pack application and neck massage.
This will be followed by chiropractic treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Assessment
Time Frame: From enrollment and at the end of treatment (at 4 weeks)
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The Pain Visual Analog Scale (VAS) is a unidimensional measure of pain intensity.
It typically consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" (0) and "worst imaginable pain" (10).
Participants are asked to mark a point on the line that best represents their current level of pain.
The distance from the "no pain" anchor to the marked point is measured in centimeters or millimeters and recorded as the pain score, with higher scores indicating greater pain intensity.
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From enrollment and at the end of treatment (at 4 weeks)
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Disability Assessment
Time Frame: Baseline and at end of treatment, 4 weeks
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The Neck Disability Index is the most widely used and most strongly validated tool for assessing self-assessed disability in patients with neck pain.
It has been used effectively in both clinical and research settings in the treatment of this very common problem.Each question is scored on a scale of 0-5; the total score is expressed as a percentage between 0-100 (or 0-50 points).
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Baseline and at end of treatment, 4 weeks
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Joint Position sense assessment
Time Frame: Baseline and at end of treatment, 4 weeks
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It is an objective test used to assess the proprioceptive function (position sense) of the neck. It is used to measure whether cervical proprioception is impaired in individuals with neck pain and the effectiveness of interventions such as manual therapy (Cheng et al., 2010). Required Materials: Laser pointer or reflective marker. Headband (to secure the laser) Target point or reference frame (A point or circle can be drawn on the wall.) Goniometer or motion analyzer (Optional.) |
Baseline and at end of treatment, 4 weeks
|
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Fear avoidance questionnaire
Time Frame: Baseline and at end of treatment, 4 weeks
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It aims to comprehensively assess the cognitive, behavioral, and sensory components of fear-avoidance behavior in patients with painful medical conditions.
Each item is scored on a 6-point Likert scale from 0, "Strongly disagree," to 5, "Strongly agree."
The total score indicates one of several severity levels ranging from 0 to 100.
The best score is 0 and the worst score is 100.
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Baseline and at end of treatment, 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life assessment
Time Frame: Baseline and at end of treatment, 4 weeks
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The SF-36 measures eight scales: physical function, physical role, bodily pain, general health, vitality, social function, sensory role, and mental health.
Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension represented by the Physical Component Summary and a dimension represented by the Mental Component Summary.
All scales contribute to the scoring of both physical and mental measures at different rates.
The SF-36 comprises eight subscales (physical functioning, physical role functioning, emotional role functioning, energy, mental health, social functioning, body pain, and general health), and a separate score is calculated for each subscale.
The scores for the subscales range from 0 to 100.
Higher scores on the scale indicate an improvement in quality of life, whilst lower scores indicate a decline in quality of life
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Baseline and at end of treatment, 4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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