Back PainNCT05585294
Water Versus Land Based Perturbation Exercises in Elderly Participants With Back Pain
A study testing Exercises in people with Back Pain and Back Pain With Radiation, run by Gulf Medical University at 2 sites in United Arab Emirates.
Trial summary
The aim of this study was to compare the effectiveness of land based versus water based perturbation exercises on the pain, disability, fear of falling, and fear avoidance beliefs in elderly participants. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Back Pain, Back Pain With Radiation, Back Pain Without Radiation
- What is being tested?
- Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 21 Dec 2019to 30 Nov 2022
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain history of minimum 12 weeks duration in below labels
- Participants with the diagnostic labels of spondylosis
- Non-specific chronic low back pain
- Back pain radiating to leg or sciatica
- Subacute back pain
Who cannot join
- Unstable blood pressure
- Cardiac failure
- Incontinence
- Uncontrolled epilepsy
- Open wounds
- Acute infections
Show all 9Show fewer
- Neurological disorders
- Orthopedic conditions affecting exercise participation in pool and land
- Cardio-respiratory conditions affecting exercise participation in pool and land.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites
Gulf Medical University, Thumbay Physical Therapy and Rehabiliation Hospital, Thumbay University Hospital
Ajman
Gulf Medical University
Ajman
About this study
Official title: The Effectiveness of Perturbation Exercises in Elderly Back Pain
The aim of this study was to compare the effectiveness of land based versus water based perturbation exercises on the pain, disability, fear of falling, and fear avoidance beliefs in elderly participants. Overweight/obese subgroup was compared with healthy weight with chronic low back pain participants to investigate any effect on BMI on both interventions. The results of the study revealed that both exercise groups i.e., land and water based exercise had a significant reduction in pain level, fear of falling, fear avoidance belief related to work, disability and improved SLR.
Read the detailed description
Twenty-four grouped into 12 per group participated water based and land based exercise protocol. Both groups were given McKenzie Method of exercises in 1st week based on the treatment-based classification (TBC) approach or personalized to the need of participants as per TBC.
Perturbation-based postural exercises were given to participants, which were performed on land or water for 6 weeks.
The perturbation based exercises were categorized into four levels, where level 1:static postural control, 2:dynamic postural control 3:Extremity loaded postural control and 4: cognitive task associated postural control. The perturbation were provided at shoulder and hip level, by intervention providers progressive enough to initiate anticipatory or compensatory postural adjustments.
Both groups were educated on pain assurance and spinal ergonomics feedback. The Outcomes were measured using a Visual analog scale, Oswestry disability index, Fear avoidance belief questionnaire, Straight leg raise, Modified fall efficacy scale, and Borg scale. The pain level were assessed for personalized progression from level 1 to level 4 progression of perturbation exercises.
Both the exercise groups of land and water showed improvement in measured clinical outcomes in terms of reduction in pain level, fear of falling, fear avoidance belief related to work, SLR, and disability. Water-based group showed additional benefits and significant improvement in fear avoidance belief related to physical activity and exercised with low rate of perceived exertion.
- Conditions
- Back Pain, Back Pain With Radiation, Back Pain Without Radiation, Back Pain Lower Back Chronic
- Being tested
- Exercises
- Keywords
- Back Pain, Old Age, Exercises, Hydrotherapy, Rehabilitation
- Medical subject headings
- Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesBehavioural
Also called Mckenzie extension exercise, mobilization and spinal lumbar traction therapy tailored based on TBC system
Perturbation exercises: A new protocol of perturbation exercises aimed to disturb static and dynamic posture or equilibrium at primarily at body segments at hip and shoulder level were provided. The perturbation was initially started as anticipatory postural adjustment and progressed to compensatory postural adjustment, where stepping on various directions were challenged. The nature of perturbation or push or nudges applied by physiotherapists were progressed from a) self-generated to therapist applied, anticipated to unanticipated, stable to unstable platforms, static to dynamic postural tasks with loaded extremities and at higher level simple to higher cognitive tasks were also incorporated.
| Study group | Role | What they receive |
|---|---|---|
| Water based perturbation exercise group | Experimental | In both groups, the participants screened for Treatment-based classification of back pain and based on TBC interventions were provided. From second week, water based perturbation exercise were initiated personalized to the level of participants.
Treatment-based classification of back pain intervention was gradually tapered in orderly fashion during 6 weeks, concurrently introduced land based perturbation exercise gradually phased from level 1 to level 4. Receives: Behavioral: Exercises |
| Land based perturbation exercise group | Active comparator | All procedures were followed similar to Water based perturbation exercise group except perturbation based exercises were provided in land. Receives: Behavioral: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
Visual Analogue Scale (VAS) was used where 0 indicates no pain and 10 indicate extremely painful.
Measured: 6 weeks
Disability caused by the chronic low back pain
A standard Oswestry Disability Index (ODI) was used to evaluate the disability caused by the chronic low back pain. The lower the score lower disability and higher scores indicates that high level of disability associated with back pain.
Measured: 6 weeks
Physical activity associated fear avoidance behavior
The percentage of fear avoidance of behavior ranges from 0 to 100% where 0%-indicates no fear and 100%-indicate highest level of fear avoidance behavior.
Measured: 6 weeks
Fall risk
Fall risk of participants was assessed using the Modified fall efficacy scale (MFES), where Higher scores reflect more confidence and less fear of falling while lower scores reflect less confidence and more fear of falling.
Measured: 6 weeks
Secondary outcomes (2)
Rate of perceived exertion
Borg scale utilised to measue the exertion during the exercise. Grades were obtained with 6 being no exertion at all, and 20 being maximum effort.
Measured: 6 weeks
Impairment - Straight Leg Raise as hip joint range of motion
Straight leg raise range of motion was measured to identify the level of impairment and to confirm any leg pain associated with back pain
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start21 Dec 2019
- Primary completion1 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- pre and post outcomes comparison after clinical intervention
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Srinivas University
- Responsible party
- Principal investigator, Rania Zaarour, Gulf Medical University
- Investigators
- Dr. Ramprasad Muthukrishnan, Ph.D, Principal investigator, Gulf Medical Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585294
- Sponsor's protocol ID
- INT/COHS/UG/012-2019
- Other IDs
- COHS_UG_Research_6122017
- Status last verified
- Apr 2023
- First submitted
- 13 Oct 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon receipt of a request from other parties, for scientific purposes such as Systematic review and meta-analysis, the data will be shared, without disclosing the personal data.
Publications
Muthukrishan R, Badr Ul Islam FM, Shanmugam S, Arulsingh W, Gopal K, Kandakurti PK, Rajasekar S, Malik GS, S G G. Perturbation-based Balance Training in Adults Aged Above 55 Years with Chronic Low Back Pain: A Comparison of Effects of Water versus Land Medium - A Preliminary Randomized Trial. Curr Aging Sci. 2024;17(2):156-168. doi: 10.2174/0118746098254991231125143735.
PubMed 38111118
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Perturbation Exercises in Elderly Back Pain
- ClinicalTrials.gov ID
- NCT05585294
- Acronym / sponsor ID
- INT/COHS/UG/012-2019
- Conditions
- Back Pain, Back Pain With Radiation, Back Pain Without Radiation, Back Pain Lower Back Chronic
- Keywords
- Back Pain, Old Age, Exercises, Hydrotherapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Collaborators
- Srinivas University
- Study start
- 21 Dec 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 18 Oct 2022 (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.
The aim of this study was to compare the effectiveness of land based versus water based perturbation exercises on the pain, disability, fear of falling, and fear avoidance beliefs in elderly participants. Overweight/obese subgroup was compared with healthy weight with chronic low back pain participants to investigate any effect on BMI on both interventions. The results of the study revealed that both exercise groups i.e., land and water based exercise had a significant reduction in pain level, fear of falling, fear avoidance belief related to work, disability and improved SLR.
Detailed description
Twenty-four grouped into 12 per group participated water based and land based exercise protocol. Both groups were given McKenzie Method of exercises in 1st week based on the treatment-based classification (TBC) approach or personalized to the need of participants as per TBC.
Perturbation-based postural exercises were given to participants, which were performed on land or water for 6 weeks.
The perturbation based exercises were categorized into four levels, where level 1:static postural control, 2:dynamic postural control 3:Extremity loaded postural control and 4: cognitive task associated postural control. The perturbation were provided at shoulder and hip level, by intervention providers progressive enough to initiate anticipatory or compensatory postural adjustments.
Both groups were educated on pain assurance and spinal ergonomics feedback. The Outcomes were measured using a Visual analog scale, Oswestry disability index, Fear avoidance belief questionnaire, Straight leg raise, Modified fall efficacy scale, and Borg scale. The pain level were assessed for personalized progression from level 1 to level 4 progression of perturbation exercises.
Both the exercise groups of land and water showed improvement in measured clinical outcomes in terms of reduction in pain level, fear of falling, fear avoidance belief related to work, SLR, and disability. Water-based group showed additional benefits and significant improvement in fear avoidance belief related to physical activity and exercised with low rate of perceived exertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- pre and post outcomes comparison after clinical intervention
| Arm | Type | Receives |
|---|---|---|
| Water based perturbation exercise group | Experimental | Behavioral: ExercisesIn both groups, the participants screened for Treatment-based classification of back pain and based on TBC interventions were provided. From second week, water based perturbation exercise were initiated personalized to the level of participants. Treatment-based classification of back pain intervention was gradually tapered in orderly fashion during 6 weeks, concurrently introduced land based perturbation exercise gradually phased from level 1 to level 4. |
| Land based perturbation exercise group | Active comparator | Behavioral: ExercisesAll procedures were followed similar to Water based perturbation exercise group except perturbation based exercises were provided in land. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain history of minimum 12 weeks duration in below labels
- Participants with the diagnostic labels of spondylosis
- Non-specific chronic low back pain
- Back pain radiating to leg or sciatica
- Subacute back pain
Key exclusion criteria (9 listed)
- Unstable blood pressure
- Cardiac failure
- Incontinence
- Uncontrolled epilepsy
- Open wounds
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 |
|---|---|---|
| ExercisesAlso: Mckenzie extension exercise, mobilization and spinal lumbar traction therapy tailored based on TBC systemPerturbation exercises: A new protocol of perturbation exercises aimed to disturb static and dynamic posture or equilibrium at primarily at body segments at hip and shoulder level were provided. The perturbation was initially started as anticipatory postural adjustment and progressed to compensatory postural adjustment, where stepping on various directions were challenged. The nature of perturbation or push or nudges applied by physiotherapists were progressed from a) self-generated to therapist applied, anticipated to unanticipated, stable to unstable platforms, static to dynamic postural tasks with loaded extremities and at higher level simple to higher cognitive tasks were also incorporated. | Behavioural | Land based perturbation exercise group, Water based perturbation exercise group |
Primary outcome
Low back pain
Time frame: 6 weeks
Visual Analogue Scale (VAS) was used where 0 indicates no pain and 10 indicate extremely painful.
Disability caused by the chronic low back pain
Time frame: 6 weeks
A standard Oswestry Disability Index (ODI) was used to evaluate the disability caused by the chronic low back pain. The lower the score lower disability and higher scores indicates that high level of disability associated with back pain.
Physical activity associated fear avoidance behavior
Time frame: 6 weeks
The percentage of fear avoidance of behavior ranges from 0 to 100% where 0%-indicates no fear and 100%-indicate highest level of fear avoidance behavior.
Fall risk
Time frame: 6 weeks
Fall risk of participants was assessed using the Modified fall efficacy scale (MFES), where Higher scores reflect more confidence and less fear of falling while lower scores reflect less confidence and more fear of falling.
2 secondary outcomes
Rate of perceived exertion
Time frame: 6 weeks
Impairment - Straight Leg Raise as hip joint range of motion
Time frame: 6 weeks
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 14 Apr 2023.
- Derived from this study: PubMed 38111118Muthukrishan R, Badr Ul Islam FM, Shanmugam S, Arulsingh W, Gopal K, Kandakurti PK, Rajasekar S, Malik GS, S G G. Perturbation-based Balance Training in Adults Aged Above 55 Years with Chronic Low Back Pain: A Comparison of Effects of Water versus Land Medium - A Preliminary Randomized Trial. Curr Aging Sci. 2024;17(2):156-168. doi: 10.2174/0118746098254991231125143735.
- Individual participant dataSharing planned: Yes. Upon receipt of a request from other parties, for scientific purposes such as Systematic review and meta-analysis, the data will be shared, without disclosing the personal data.
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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.
Dr. Ramprasad Muthukrishnan, Ph.D principal investigator
Gulf Medical Univesity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Back Pain and Back Pain With Radiation, run by Gulf Medical University at 2 sites in United Arab Emirates.
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 5 inclusion and 9 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 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. 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?
Low back pain (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05585294, which also lists 1 linked publication.
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 14 Apr 2023.