- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06894355
Group Hydrotherapy Treatment for Athletes With Lower Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low back pain is a common issue in Western society, especially among athletes who experience significant physical stress. One effective conservative treatment method is hydrotherapy, which involves exercising in water. This approach takes advantage of water's properties, such as buoyancy, weight reduction, and resistance. By using these properties, individuals can perform movements and exercises that may be painful or difficult to do on land.
The purpose of the study is to examine the effect of group hydrotherapy on chronic low back pain and function among athletes.
The study will involve participants with chronic back pain who will complete a 6-week intervention program led by a certified physiotherapist, including hydrotherapy treatment and guidance for independent exercises.
The exercise will include reduced-weight activities at waist-to-neck depth, resistance exercises at varying depths, and the utilization of buoyancy and resistance devices.
The evaluation indicators will be taken before and after the intervention period and will include: a demographic questionnaire, history of back pain and anthropometric details (height, weight), Oswestry questionnaire to assess function following back pain, a visual analog scale to assess the maximum degree of pain during the day, hip range tests, a forward flexion distance test, and a back alignment test. At the end of the intervention, a global rating of scale questionnaire will also be taken to assess the effectiveness of the improvement.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gali Dar, PhD
- Phone Number: +972505662054
- Email: galidar@yahoo.com
Study Locations
-
-
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Netanya, Israel
- Recruiting
- Wingate institue
-
Contact:
- Alon Yechiel, M.Sc
- Phone Number: +97298639426
- Email: alon.yehiel@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Athletes who complain of low back pain for over 3 months,
- VAS>3
- train more than 5 times a week.
Exclusion Criteria:
- acute back pain
- neurological signs (decreased muscle strength, decreased reflexes, radiating to the leg).
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 |
|---|---|
|
Experimental: Hydrotherapy
Participants will undergo hydrotherapy in addition to regular physical therapy
|
hydrotherapy in addition to physical therapy
|
|
Active Comparator: control
Participants will go through regular physical therapy treatments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in Visual analog scale
Time Frame: base line, up to 8 weeks
|
assessing pain on a scale from 0 (no pain) to 10 (most sever pain).
Higher scores means worse outcome.
|
base line, up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in forward flexion distance test
Time Frame: base line, up to 8 weeks
|
lumbar flexion assessment by bending forward and measuring distance of fingers from the floor
|
base line, up to 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
outcome measurement results will be shared between therapists performing the study and the principal investigator.
protocol, results and conclusion will be published via professional paper without patients details.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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