Condition category
Musculoskeletal Diseases
Date applied
06/07/2018
Date assigned
19/07/2018
Last edited
20/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Non-specific chronic low back pain (nscLBP) is a highly relevant condition, due to its prevalence and associated costs. Therefore, it is important to look at effective ways to treat nscLBP. Green exercise (exercise in natural environments) and balneotherapy (bathing in thermal mineral springs) are seen as good treatment options, but there have been no scientific trials to determine the effectiveness of these therapies.
This trial aimed to determine whether moderate mountain hiking, a form of green exercise alone or combined with bathing in thermal water (Mg-Ca-SO₄ balneotherapy) is an effective, economic nature therapy to reduce the symptoms and improve the wellbeing of patients with non-specified chronic low back pain.

Who can participate?
Men and women aged 19-65 with diagnosed non-specific chronic low back pain (ncsLBP) who have received repeated medical treatment as a result.

What does the study involve?
Participants are randomly allocated to either the control group or one of two intervention groups – GE (green exercise) or GEBT (green exercise and balneotherapy).
The GE and GEBT groups spend 8 days in the village of Grins (Tyrol, Austria) in comparable hotels and receive the same meals. Participants in both groups receive a medical assessment (day 0) upon arrival on Saturday. On Sunday to Friday, GE and GEBT participants undertake daily guided hiking tours in the mountains (green exercise). On the following Saturday (day 8), participants in both groups receive an identical medical assessment to their arrival and then depart. Participants in the GEBT group also undertake daily 20 minute baths in thermal water. Participants receive the same medical assessment again at day 120.
Participants in the control group only receive the same medical assessments as GE and GEBT participants at day 0, day 8 and day 120.

What are the possible benefits and risks of participating?
The possible benefit to participants of taking part is relief from their nscLBP symptoms. However, a possible risk of taking part is that it may aggravate their nscLBP symptoms. Aside from this, there are no known benefits or risks to participants.

Where is the study run from?
Trial study centre: Grins, Tyrol, Austria
Trial run from: Paracelsus Medical University of Salzburg, Strubergasse 22, 5020 Salzburg, Austria

When is the study starting and how long is it expected to run for?
March 2012 to March 2015

Who is funding the study?
EU-Leader Project (regioL, Health and Energy) (Austria)

Who is the main contact?
Arnulf Hartl
arnulf.hartl@pmu.ac.at

Trial website

Contact information

Type

Scientific

Primary contact

Dr Arnulf Hartl

ORCID ID

Contact details

Strubergasse 22
Salzburg
5020
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

415-E/1487/4-2012

Study information

Scientific title

Green exercise and Mg-Ca-SO4 thermal balneotherapy for the treatment of non-specific chronic low back pain: a randomized controlled clinical trial

Acronym

N/A

Study hypothesis

This randomised controlled trial was conducted to find out whether green exercise - in this case moderate mountain hiking - combined with Mg-Ca-SO4 thermal balneotherapy is an effective and economic nature therapy to reduce symptoms and improve wellbeing of patients with nscLBP

Ethics approval

Ethikkommission für das Bundesland Salzburg, 04/05/2012, 415-E/1487/4-2012

Study design

Interventional three-armed randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Non-specific chronic low back pain (nscLBP)

Intervention

Participants were stratified by the Korff assessment (pain related disability) and then separated into three groups (control and two intervention groups) using Random Allocation Software 2.0 using block randomisation. The two intervention groups were green exercise (GE) and green exercise and balneotherapy (GEBT).
Participants in the GE and GEBT groups spent 8 days at the village of Grins (Tyrol, Austria) in comparable hotels and received the same meals. Participants arrived on Saturday and underwent medical measurements and anamnesis of their medical history (day 0). Medical measurements involved use of the Oswestry Low Back Disability Index, Medical Outcomes Study Short Form 36, Modified Visual Analogue Scale, World Health Organisation Well-Being Index, a pain diary, assessment of medical consultations and days of incapacity to work, along with Spine-Check Score MediMouse®, Back Performance Scale and torso rotation.
From Sunday to Friday, participants undertook guided hiking tours (green exercise) in the mountains. On the following Saturday, all participants underwent identical medical assessment (day 8) to their arrival day, and departed after this was completed. Follow-up examinations were conducted on day 120.
Participants in the GE group participated in green exercise only. Participants in the GEBT group participated in green exercise and also received balneotherapy, where they bathed in Mg-Ca-SO₄ thermal water in the Albenbad every day for 20 minutes.
Participants in the control group underwent no intervention and only underwent the medical measurements and anamnesis listed above at day 0, day 8 and day 120.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Functional spine mobility measured using MediMouse (Spine Check Score) at day 0, 8 and 120.

Secondary outcome measures

The following were measured at day 0, 8 and 120:
1. Subjective pain assessed using the mVAS
2. Status of health assessed using the mVAS
3. Back performance assessed using parts of the Back Performance Scale (sock test left/right and lift test)
4. Torso/spine rotation measured using digital goniometer
5. Health-related quality of life assessed using SF-36 questionnaire
6. Depression in chronic illness assessed using WHO-5 questionnaire
7. Claim of medical care assessed through querying pain medication, status of illness and number of medical consulations
8. Pain behaviour and activities of daily living for patients with cLBP measured using Oswestry Disability Index

Overall trial start date

01/03/2012

Overall trial end date

01/03/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosed with non-specific low back pain (nscLBP)
2. Aged 19-65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Total final enrolment

80

Participant exclusion criteria

1. Previous operations in lumbar spine area
2. Suspected disc herniation
3. Acute pain in low back area
4. Confirmed osteoporosis
5. Hernia
6. Pregnancy
7. Contraindications of balneotherapy, including:
7.1. Cardiovascular dysfunction (e.g. unstable hypertension, angina pectoris, thrombosis, pulmonary dysfunction, endocrine disorders such as hyperthyroidism and hyperparathyroidism)
7.2. Uncontrolled metabolic disorders (e.g. diabetes mellitus)
7.3. Active infectious diseases
7.4. Incontinence

Recruitment start date

01/03/2013

Recruitment end date

01/07/2013

Locations

Countries of recruitment

Austria, Germany

Trial participating centre

Paracelsus Medical University
Strubergasse 22
Salzburg
5020
Austria

Sponsor information

Organisation

This project was funded by an EU-Leader Project (regioL, Health and Energy).

Sponsor details

Strubergasse 22
Salzburg
5020
Austria

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

This project was funded by an EU-Leader Project (regioL, Health and Energy).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in PLoS ONE (peer-reviewed journal)

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Arnulf Hartl (arnulf.hartl@pmu.ac.at), with individual deidentified participant data available, along with the study protocol and informed consent form. Data will be available from 9 months until 36 months following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose - it will be available for individual participant data meta-analysis.

, type of data, when the data will become available and for how long, by what access criteria data will be shared including with whom, for what types of analyses, and by what mechanism, whether consent from participants was obtained, comments on data anonymisation, any ethical or legal restrictions, any other comments)

Intention to publish date

11/07/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31096958 (added 20/05/2019).

Publication citations

Additional files

Editorial Notes

20/05/2019: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added.