NCT06894355

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

January 28, 2025

Last Update Submit

June 19, 2025

Conditions

Keywords

hydrotherapy, low back pain, group, athlete

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • change in forward flexion distance test

    base line, up to 8 weeks

Study Arms (2)

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

hydrotherapy in addition to physical therapy

Hydrotherapy

regular physical therapy treatments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Athletes who complain of low back pain for over 3 months,
  • VAS\>3
  • train more than 5 times a week.

You may not qualify if:

  • acute back pain
  • neurological signs (decreased muscle strength, decreased reflexes, radiating to the leg).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingate institue

Netanya, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38763585BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

HydrotherapyControl Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitationEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Gali Dar, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The interventional group will undergo hydrotherapy treatment in addition to physical therapy treatments The control group will undergo regular physical therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dar , researcher, Department of Physical Therapy, University of Haifa

Study Record Dates

First Submitted

January 28, 2025

First Posted

March 25, 2025

Study Start

June 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
data will be shared 6 months following the completion of the study
Access Criteria
The principal investigator will share the IPD and supporting information with the therapist performing the intervention.

Locations