Comparison of the Clinical Effect on Common Low Back Pain of a Thermal Cure With Dry Rehabilitation

NCT06947863 | Completed

• 1 other identifier: ONT-HMS
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To compare the benefits, with regard to low back pain (LBP) symptoms, of a thermal cure and a dry rehabilitation treatment. Methods: Randomized therapeutic trial including patients with LBP, randomly divided into two groups. Thermal cure consisted of underwater shower, massage-jet showers, hydro-massage, pool rehabilitation and peloid therapy. Dry rehabilitation consisted of analgesic physiotherapy, muscle strengthening and group physical rehabilitation. The primary endpoint was based on the Visual Analog Scale (VAS) of pain at day 18 (Day 18). The other outcome measures were the Oswestry Disability Index (ODI), the Short Form-36 (SF36) questionnaire and spine mobility. Follow-up was carried out for 12 months.

Conditions

Low Back Pain

Keywords

crenobalneotherapy; thermal cure; rehabilitation; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• VAS pain

  Pain was assessed using a visual analog scale (VAS) with a vertically held ruler graduated from 0 to 10. The VAS score for low back pain was then expressed in millimeters, ranging from 0 mm (no pain) to 100 mm (maximum pain). The primary endpoint was VAS pain, blindly assessed by the same doctor for each patient on the last day of the treatment (Day 18).

  Day 18

Secondary Outcomes (4)

• VAS pain

  at 3 months, 6 months and 12 months after the end of the treatment

• the OSWESTRY Disability Index (ODI)

  at Day 18, month 3, month 6 and month 12.

• the quality of life score SF-36

  at Day 18, month 3, month 6 and month 12

• spinal mobility

  at Day 18, month 3, month 6 and month 12

Study Arms (2)

Thermal cure

ACTIVE COMPARATOR

The thermal treatment used hot, chlorinated and sodium water. Every day, the patients received 4 out of the 5 following treatments: underwater showers (15 minutes), shower-massage (10 minutes), hydromassage (20 minutes), swimming pool rehabilitation (20 minutes) and application of heated peloid (15 minutes). Patients were accommodated in the care center for 18 days. Treatments were delivered in the morning on a daily basis, except on Sundays.

Other: thermal cure

dry rehabilitation

ACTIVE COMPARATOR

The thermal treatment used hot, chlorinated and sodium water. Every day, the patients received 4 out of the 5 following treatments: underwater showers (15 minutes), shower-massage (10 minutes), hydromassage (20 minutes), swimming pool rehabilitation (20 minutes) and application of heated peloid (15 minutes).

Other: dry rehabilitation

Interventions

thermal cure OTHER

The thermal treatment and physical rehabilitation therapy were administered at the same spa center of Jbal EL Ouest, situated to the west of the city of Zaghouan, 50 km from Tunis. Patients were accommodated in the care center for 18 days. Treatments were delivered in the morning on a daily basis, except on Sundays. The thermal treatment used hot, chlorinated and sodium water. Every day, the patients received 4 out of the 5 following treatments: underwater showers (15 minutes), shower-massage (10 minutes), hydromassage (20 minutes), swimming pool rehabilitation (20 minutes) and application of heated peloid (15 minutes).

Thermal cure

dry rehabilitation OTHER

The thermal treatment and physical rehabilitation therapy were administered at the same spa center of Jbal EL Ouest, situated to the west of the city of Zaghouan, 50 km from Tunis. Patients were accommodated in the care center for 18 days. Treatments were delivered in the morning on a daily basis, except on Sundays. The physical rehabilitation treatment was delivered in dry and included an analgesic physiotherapy based on electrotherapy (30 minutes) and muscle strengthening, as well as group rehabilitation.

Also known as: physical rehabilitation

dry rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with low back pain (LBP) evolving for more than 12 weeks.
• Visual analog scale (VAS) of pain greater than 30.

You may not qualify if:

• Patients with a loss of autonomy or with impaired intellectual abilities
• Patients with contraindications to a thermal cure (infectious or progressive inflammatory pathologies, unbalanced blood hypertension, decompensated heart disease, respiratory failure, decompensated neurological or psychiatric illness, age greater than 75 years, pregnancy, purulent skin lesions).
• Patients having undergone an epidural infiltration (within 3 months) or spinal surgery (within 1 year)

Sponsors & Collaborators

• Tunis University: lead

Study Sites (1)

Mongi Slim Hospital

La Marsa, Sidi Daoued, 2046, Tunisia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Laatar, Professor

  Rheumatology department, Mongi Slim Hospital, La Marsa, Tunisia

  STUDY CHAIR

• Alia Fazaa, Associate Professor

  Rheumatology department, Mongi Slim Hospital, la Marsa, Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the doctors participating in the study nor the patients were informed beforehand of the type of treatment that will be delivered, thermal cure (group 1) or dry rehabilitation (group 2). Each group of patients was unaware of the existence of the other group and its type of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The choice of the type of treatment to be delivered was determined by means of randomization provided by the senior investigator in accordance with the Zelen method. Neither the doctors participating in the study nor the patients were informed beforehand of the type of treatment that will be delivered, thermal cure (group 1) or dry rehabilitation (group 2). To calculate the number of subjects required in a group, we set alpha risk at 0.05, beta risk at 0.2 and the minimum difference of pain visual analog scale (VAS) to be highlighted between the 2 groups at 20 out of 100. To generate the randomization sequence, we randomly established a list of numbers using the EpiTable program in Epi Info (6.04d version), assigning treatment 1 to odd numbers and treatment 2 to even numbers. The number of patients was balanced after each 20-number sequence. Two groups of 37 patients each were formed. The patients were divided into 4 contingents.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 27, 2025
• Study Start: April 3, 2017
• Primary Completion: April 13, 2018
• Study Completion: April 12, 2019
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)