Group Hydrotherapy Treatment for Athletes With Lower Back... | NCT06894355

Studies
Group Hydrotherapy Treatment for Athletes With Lower Back Pain

NCT06894355

Sponsor

Gali Dar

Status

Recruiting

Last Update Posted

Jun 25, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

hydrotherapy
control group

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Jan 1, 2026Estimated

First Submitted Date

Jan 28, 2025

First Submission Date that Met QC Criteria

Mar 24, 2025

First Posted Date

Mar 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2025

Last Update Posted Date

Jun 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gali Dar, Prof. Dar , researcher, Department of Physical Therapy, University of Haifa, University of HaifaSponsor-Investigator

Lead Sponsor

Gali DarOTHER

Collaborators

Name	Class
Wingate Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The effect of group hydrotherapy on chronic low back pain and function among athletes will be examined.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrotherapy	Experimental	Participants will undergo hydrotherapy in addition to regular physical therapy	Other: hydrotherapy
control	Active Comparator	Participants will go through regular physical therapy treatments

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hydrotherapy	Other	hydrotherapy in addition to physical therapy	Hydrotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in Visual analog scale	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 Outcomes

Measure	Description	Time Frame
change in forward flexion distance test	lumbar flexion assessment by bending forward and measuring distance of fingers from the floor	base line, up to 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gali Dar, PhD	Contact	+972505662054		galidar@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wingate institue	Recruiting	Netanya			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38763585	Result	Peretro G, Ballico AL, Avelar NC, Haupenthal DPDS, Arcencio L, Haupenthal A. Comparison of aquatic physiotherapy and therapeutic exercise in patients with chronic low back pain. J Bodyw Mov Ther. 2024 Apr;38:399-405. doi: 10.1016/j.jbmt.2023.10.006. Epub 2024 Jan 16.

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D006875	Hydrotherapy
D035061	Control Groups

ID	Term
D026741	Physical Therapy Modalities
D013812	Therapeutics
D012046	Rehabilitation
D015340	Epidemiologic Research Design