Low Back PainNCT06947863
Comparison of the Clinical Effect on Common Low Back Pain of a Thermal Cure With Dry Rehabilitation
A study testing thermal cure and dry rehabilitation in people with Low Back Pain, run by Tunis University at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- thermal cure and dry rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTunisia
- Study dates
- 3 Apr 2017to 12 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with low back pain (LBP) evolving for more than 12 weeks.
- Visual analog scale (VAS) of pain greater than 30.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Clinical Effect on Common Low Back Pain of a Thermal Cure With Dry Rehabilitation: A Randomized Therapeutic Trial
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- thermal cure, dry rehabilitation
- Keywords
- crenobalneotherapy, thermal cure, rehabilitation, randomized controlled trial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal cureOther
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).
dry rehabilitationOther
Also called physical rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: dry rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 18
Secondary outcomes (4)
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 secondary criteria were represented by the VAS pain at 3 months, 6 months and 12 months after the end of the treatment.
Measured: at 3 months, 6 months and 12 months after the end of the treatment
the OSWESTRY Disability Index (ODI)
Functional capacity was assessed using the Oswestry Disability Index (ODI), for which the Arabic language version has been validated. It is a self-administered questionnaire consisting of eight items (pain, personal care, lifting, walking difficulties, sitting and standing positions, sleep, and social life). Each item includes six response options scored from 0 to 5. The total score is expressed as a percentage of disability, ranging from 0% (no disability) to 100% (total disability).
Measured: at Day 18, month 3, month 6 and month 12.
the quality of life score SF-36
Patients' quality of life was assessed using the 36-Item Short Form Health Survey (SF-36), for which a validated Arabic version is available.The questionnaire includes 36 items assessing eight dimensions of quality of life: physical functioning, physical role limitations, bodily pain, general health, vitality, social functioning, emotional role limitations, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better quality of life. The scores from the eight dimensions are used to calculate two summary scores: the Physical Component Summary (PCS), which includes physical functioning, physical role limitations, bodily pain, and general health; and the Mental Component Summary (MCS), which includes vitality, social functioning, emotional role limitations, and mental health.
Measured: at Day 18, month 3, month 6 and month 12
spinal mobility
Assessment of Spinal Mobility The Schöber index assesses lumbar spine flexibility. It measures the distance between a horizontal landmark at the level of the L5 vertebra and a second landmark located 10 centimeters above it during maximal trunk flexion with feet together. A normal value is +5 cm.
The fingertip-to-floor distance in forward flexion refers to the distance between the floor and the tip of the middle finger during maximal trunk flexion with feet together. The normal value is 0 cm.
The fingertip-to-floor distance in lateral flexion is the difference between the fingertip-to-floor distance in the neutral position and that in lateral bending, with the iliac crest stabilized. It is expressed in centimeters.
Inverse Schöber Index measures the distance between a horizontal landmark at the level of the L5 vertebra and a point 10 cm below it during maximal trunk extension
Measured: at Day 18, month 3, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start3 Apr 2017
- Primary completion13 Apr 2018
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazaa Alia, Tunis University
- Investigators
- Ahmed Laatar, Professor, Study chair, Rheumatology department, Mongi Slim Hospital, La Marsa, TunisiaAlia Fazaa, Associate Professor, Principal investigator, Rheumatology department, Mongi Slim Hospital, la Marsa, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947863
- Sponsor's protocol ID
- ONT-HMS
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effect on Common Low Back Pain of a Thermal Cure With Dry Rehabilitation: A Randomized Therapeutic Trial
- ClinicalTrials.gov ID
- NCT06947863
- Acronym / sponsor ID
- ONT-HMS
- Conditions
- Low Back Pain
- Keywords
- crenobalneotherapy, thermal cure, rehabilitation, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thermal cure | Active comparator | Other: thermal cureThe 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. |
| dry rehabilitation | Active comparator | Other: dry rehabilitationThe 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with low back pain (LBP) evolving for more than 12 weeks.
- Visual analog scale (VAS) of pain greater than 30.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thermal cureThe 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). | Other | Thermal cure |
| dry rehabilitationAlso: physical rehabilitationThe 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. | Other | dry rehabilitation |
Primary outcome
VAS pain
Time frame: Day 18
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).
4 secondary outcomes
VAS pain
Time frame: at 3 months, 6 months and 12 months after the end of the treatment
the OSWESTRY Disability Index (ODI)
Time frame: at Day 18, month 3, month 6 and month 12.
the quality of life score SF-36
Time frame: at Day 18, month 3, month 6 and month 12
spinal mobility
Time frame: at Day 18, month 3, month 6 and month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Laatar, Professor study chair
Rheumatology department, Mongi Slim Hospital, La Marsa, Tunisia
Alia Fazaa, Associate Professor principal investigator
Rheumatology department, Mongi Slim Hospital, la Marsa, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermal cure and dry rehabilitation in people with Low Back Pain, run by Tunis University at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain (time frame: Day 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.