Chronic Low-back PainNCT04378413
Aquatic and Land Exercises in Chronic Low Back Pain
A study testing exercise in people with Chronic Low-back Pain, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Aquatic and Land Exercises on Chronic Low Back Pain Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2019to 23 Apr 2020
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients had to be diagnosed with clinical examination and radiological findings of low back pain from at least 6 months.
Who cannot join
- acute pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aquatic and Land Exercises on Pain, Health Related Quality of Life, Kinesiophobia and Disability in Chronic Low Back Pain
Aquatic and Land Exercises on Chronic Low Back Pain
Read the detailed description
The Effect of Aquatic and Land Exercises on Pain, Health Related Quality of Life, Kinesiophobia and Disability in Chronic Low Back Pain
- Conditions
- Chronic Low-back Pain
- Being tested
- exercise
- Keywords
- Aquatic Exercises, Chronic Low Back Pain,, Land Exercises, Pain,, Functional status
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
exercise for low back pain
| Study group | Role | What they receive |
|---|---|---|
| The Effect of Aquatic Exercises on Pain, quality of life | Experimental | Water-based exercise program was conducted in the second group of 15 patients in an indoor swimming pool. Temperature of mineral water was 36 °C. The program included warming up by walking forwards, sideways and backwards through the water in the pool; active range of motion of the joints of the lower extremities; stretching lower extremities; strengthening exercises for hips, knees, arms, elbows and wrists; and cooling down (slow walking, squatting and standing). Receives: Other: exercise |
| The Effect of Land Exercises on Pain, Quality of life | Experimental | Land-based exercise program included abdominal and back strengthening exercises. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain in low back pain after aqua and land exercises
It is asked to mark pain on a 10 cm scale.Pain was assessed at rest and at movement by using a 10-cm-long visual (0 cm means no pain while 10 cm means worst pain
Measured: 4 week
quality of life after aqua and land exercises
Quality of life was assessed by Short-Form 36 Health Survey (SF-36) High scores indicate good quality of life and low scores represent poor quality of life.
Measured: 4 week
Secondary outcomes (2)
disability in low back paitients after aqua and land exercise
.For disability assessment, the Modified Oswestry Disability İndex was used . According to the sum of scale; 0-4 points were considered as no disability, 5-14 points were mild, 15-24 points were moderate, 25-34 points were serious, and 35-50 points were fully functional inadequacy.
Measured: 4 week
kinesiophobia in low back paitients after aqua and land exercise
The assessment of kinesiophobia was made with the Tampa Scale The fact that the individual got a high score from the questionnaire shows that she has more fear of movement.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start2 Nov 2019
- Primary completion15 Mar 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Aytar TIĞLI, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378413
- Sponsor's protocol ID
- 62310886-600
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aquatic and Land Exercises on Pain, Health Related Quality of Life, Kinesiophobia and Disability in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04378413
- Acronym / sponsor ID
- 62310886-600
- Conditions
- Chronic Low-back Pain
- Keywords
- Aquatic Exercises, Chronic Low Back Pain,, Land Exercises, Pain,, Functional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 7 May 2020 (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.
Aquatic and Land Exercises on Chronic Low Back Pain
Detailed description
The Effect of Aquatic and Land Exercises on Pain, Health Related Quality of Life, Kinesiophobia and Disability in Chronic Low Back Pain
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Effect of Aquatic Exercises on Pain, quality of life | Experimental | Other: exerciseWater-based exercise program was conducted in the second group of 15 patients in an indoor swimming pool. Temperature of mineral water was 36 °C. The program included warming up by walking forwards, sideways and backwards through the water in the pool; active range of motion of the joints of the lower extremities; stretching lower extremities; strengthening exercises for hips, knees, arms, elbows and wrists; and cooling down (slow walking, squatting and standing). |
| The Effect of Land Exercises on Pain, Quality of life | Experimental | Other: exerciseLand-based exercise program included abdominal and back strengthening exercises. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients had to be diagnosed with clinical examination and radiological findings of low back pain from at least 6 months.
Key exclusion criteria (1 listed)
- acute pain
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 |
|---|---|---|
| exerciseexercise for low back pain | Other | The Effect of Aquatic Exercises on Pain, quality of life, The Effect of Land Exercises on Pain, Quality of life |
Primary outcome
pain in low back pain after aqua and land exercises
Time frame: 4 week
It is asked to mark pain on a 10 cm scale.Pain was assessed at rest and at movement by using a 10-cm-long visual (0 cm means no pain while 10 cm means worst pain
quality of life after aqua and land exercises
Time frame: 4 week
Quality of life was assessed by Short-Form 36 Health Survey (SF-36) High scores indicate good quality of life and low scores represent poor quality of life.
2 secondary outcomes
disability in low back paitients after aqua and land exercise
Time frame: 4 week
kinesiophobia in low back paitients after aqua and land exercise
Time frame: 4 week
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 7 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Chronic Low-back Pain, run by Baskent University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 7 May 2020. 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 Turkey (Türkiye). 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?
pain in low back pain after aqua and land exercises (time frame: 4 week). The study lists 2 primary outcomes in all. 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 7 May 2020.