- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05771441
Effects of Neck Stabilization Exercise With Heat Therapies
March 6, 2023 updated by: Hilal Yeşil
Effect of Heat Therapies on Pain, Functional Status, Range of Motion, and Disability in Patients With Neck Pain
In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Chronic non-specific neck pain (NP) has become one of the main causes of disability in the adult population around the world.Several treatment options used like; exercise, manual therapy, electrotherapy, and hot treatments etc.
In this study, we aimed to determine the effects of heat therapies and neck stabilization exercises on pain, disability, range of motion, and mood of NP patients.100
patients with NP will be included.Patients will be randomyl assigned to 4 groups and will receive a total of 3 weeks of treatment.
Patients' pain levels (visual analogoue scale VAS), quality of life (short form 36), mood (Beck deppression inventory BDI), range of motion, and neck disability index were evaluated prior to treatment, at 6th and at 12th weeks.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Afyon
-
Merkez, Afyon, Turkey, 0300
- Hilal Yeşil
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients with chronic neck pain
Exclusion Criteria:
- sensory deficit on neck area, servical disc pathologies, neurological deficit, malignity, secondary causes for neck pain, active inflammation, arthritis on the neck area, serious mental health problems, pregnancy, spine surgery, and having received treatment to the cervical region in the last 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: neck stabilization exercise (NSE)
the patients who had NSE
|
neck stabilization exercise (nse)- exercise
|
|
Active Comparator: NSE + HOT PACK THERAPY
the patients who had NSE+ hot pack
|
NSE + HOT PACK THERAPY- exercise plus heat therapy
|
|
Active Comparator: NSE + infrared therapy
the patients who had NSE+ infrared therapy
|
NSE + infrared therapy- exercise plus heat therapy
|
|
Active Comparator: NSE + ultrasound therapy
the patients who had NSE+ ultrasound therapy
|
NSE + ultrasound therapy exercise plus heat therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change from baseline VAS (visual analog scale) at 6th and 12th week
Time Frame: up to 12 weeks
|
The patients were asked to make an assesment of their pain level between 0 and 10 scale
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline quality of life (short form 36) at 6th and 12th week
Time Frame: up to 12 weeks
|
The physical and mental health summary scores were the primary components used.
Scoring is on a scale of 0 to 100 and a higher score reflects better health-related quality of life.
|
up to 12 weeks
|
|
Change from baseline shoulder range of motion (ROM) at 6th and 12th week
Time Frame: up to 12 weeks
|
The patients' joint range of motion will be measured with a goniometer.
|
up to 12 weeks
|
|
Change from baseline Beck depression inventory (BDI) at 6th and 12th week
Time Frame: up to 12 weeks
|
A total Beck score (0-63) is obtained by giving each question a score of 0-3 in the survey.
17 is considered the threshold value for the degree of depression.
|
up to 12 weeks
|
|
Change from baseline neck disability index (NDI) at 6th and 12th week
Time Frame: up to 12 weeks
|
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain |
up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
March 6, 2023
First Submitted That Met QC Criteria
March 6, 2023
First Posted (Actual)
March 16, 2023
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 6, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYSHNP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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