Back to resultsEffects of Neck Stabilization Exercise With Heat Therapies
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
neck stabilization exercise (nse)
NSE + HOT PACK THERAPY
NSE + infrared therapy
NSE + ultrasound therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Neck Pain focused on measuring hot pack, exercise, ultrasound therapy
Eligibility Criteria
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
Sites / Locations
- Hilal Yeşil
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
neck stabilization exercise (NSE)
NSE + HOT PACK THERAPY
NSE + infrared therapy
NSE + ultrasound therapy
Arm Description
the patients who had NSE
the patients who had NSE+ hot pack
the patients who had NSE+ infrared therapy
the patients who had NSE+ ultrasound therapy
Outcomes
Primary Outcome Measures
change from baseline VAS (visual analog scale) at 6th and 12th week
The patients were asked to make an assesment of their pain level between 0 and 10 scale
Secondary Outcome Measures
Change from baseline quality of life (short form 36) at 6th and 12th week
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.
Change from baseline shoulder range of motion (ROM) at 6th and 12th week
The patients' joint range of motion will be measured with a goniometer.
Change from baseline Beck depression inventory (BDI) at 6th and 12th week
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.
Change from baseline neck disability index (NDI) at 6th and 12th week
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05771441
Brief Title
Effects of Neck Stabilization Exercise With Heat Therapies
Official Title
Effect of Heat Therapies on Pain, Functional Status, Range of Motion, and Disability in Patients With Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hilal Yeşil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
hot pack, exercise, ultrasound therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neck stabilization exercise (NSE)
Arm Type
Active Comparator
Arm Description
the patients who had NSE
Arm Title
NSE + HOT PACK THERAPY
Arm Type
Active Comparator
Arm Description
the patients who had NSE+ hot pack
Arm Title
NSE + infrared therapy
Arm Type
Active Comparator
Arm Description
the patients who had NSE+ infrared therapy
Arm Title
NSE + ultrasound therapy
Arm Type
Active Comparator
Arm Description
the patients who had NSE+ ultrasound therapy
Intervention Type
Other
Intervention Name(s)
neck stabilization exercise (nse)
Intervention Description
neck stabilization exercise (nse)- exercise
Intervention Type
Other
Intervention Name(s)
NSE + HOT PACK THERAPY
Intervention Description
NSE + HOT PACK THERAPY- exercise plus heat therapy
Intervention Type
Other
Intervention Name(s)
NSE + infrared therapy
Intervention Description
NSE + infrared therapy- exercise plus heat therapy
Intervention Type
Other
Intervention Name(s)
NSE + ultrasound therapy
Intervention Description
NSE + ultrasound therapy exercise plus heat therapy
Primary Outcome Measure Information:
Title
change from baseline VAS (visual analog scale) at 6th and 12th week
Description
The patients were asked to make an assesment of their pain level between 0 and 10 scale
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline quality of life (short form 36) at 6th and 12th week
Description
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.
Time Frame
up to 12 weeks
Title
Change from baseline shoulder range of motion (ROM) at 6th and 12th week
Description
The patients' joint range of motion will be measured with a goniometer.
Time Frame
up to 12 weeks
Title
Change from baseline Beck depression inventory (BDI) at 6th and 12th week
Description
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.
Time Frame
up to 12 weeks
Title
Change from baseline neck disability index (NDI) at 6th and 12th week
Description
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
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hilal Yeşil
City
Merkez
State/Province
Afyon
ZIP/Postal Code
0300
Country
Turkey
12. IPD Sharing Statement
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Effects of Neck Stabilization Exercise With Heat Therapies
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