Clinical trial NCT06947863: Comparison of the Clinical Effect on Common Low Back Pain of a Thermal Cure With Dry Rehabilitation
Official title: Comparison of the Clinical Effect on Common Low Back Pain of a Thermal Cure With Dry Rehabilitation: A Randomized Therapeutic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: crenobalneotherapy
thermal cure
rehabilitation
randomized controlled trial
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Low back pain (LBP) is a very common pathology affecting more than 80% of the population. The pain and the limitation of movements cause significant functional discomfort, resulting in some form of disability and an added handicap. It therefore constitutes a major public health problem due to its impact on the quality of life and its high socio-economic cost.

The medical care for LBP aims to reduce pain and thus improve the functional capacities of patients. Among non-drug adjuvant treatments, the role of thermal cure is far from clear. Indeed, even if the use of thermo-mineral waters for therapeutic purposes is a very old and widespread practice in rheumatology, the study of the efficiency of thermal cures in the treatment of LBP, in particular compared to dry rehabilitation, has been the subject of only a limited number of medical publications. In Tunisia, the Tunisian Hydrotherapy Office estimates that at the end of 2017 the number of spa guests reached 51,324 for all the thermal resorts. However, there are no studies evaluating the effectiveness of such treatments.

We report the results of a randomized therapeutic trial, carried out with the aim of comparing the clinical effects of thermal cures and dry rehabilitation on common LBP.

Patient selection The selection of patients to be referred to the thermal center was made among patients treated in the rheumatology department of the Mongi Slim Hospital; a university hospital center located in La Marsa and not related to the thermal center. The inclusion visit allowed the investigating doctors to collect demographic data and clinical history, in order to verify the inclusion criteria and to have the informed consent signed in French or in Arabic depending on patients' choice.

Randomization 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). Each group of patients was unaware of the existence of the other group and its type of treatment.

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 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 protocol 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). 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.

Monitoring of care progress, compliance and tolerance during the treatment was carried out by the thermal center doctor.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)
* Patients who received physical rehabilitation or balneotherapy during the year preceding inclusion, and finally patients using stage 3 analgesics (World Health Organization classification).

Primary outcomes:
measure: VAS pain
timeFrame: Day 18
Secondary outcomes:
measure: VAS pain
timeFrame: at 3 months, 6 months and 12 months after the end of the treatment
measure: the OSWESTRY Disability Index (ODI)
timeFrame: at Day 18, month 3, month 6 and month 12.
measure: the quality of life score SF-36
timeFrame: at Day 18, month 3, month 6 and month 12
measure: spinal mobility
timeFrame: at Day 18, month 3, month 6 and month 12
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Mongi Slim Hospital
state: Sidi Daoued
Study officials:
affiliation: Rheumatology department, Mongi Slim Hospital, La Marsa, Tunisia
name: Ahmed Laatar, Professor
role: STUDY_CHAIR
affiliation: Rheumatology department, Mongi Slim Hospital, la Marsa, Tunisia
name: Alia Fazaa, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: