- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05585294
Water Versus Land Based Perturbation Exercises in Elderly Participants With Back Pain
The Effectiveness of Perturbation Exercises in Elderly Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ajman, United Arab Emirates
- Gulf Medical University
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Ajman, United Arab Emirates
- Gulf Medical University, Thumbay Physical Therapy and Rehabiliation Hospital, Thumbay University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unstable blood pressure
- Cardiac failure
- Incontinence
- Uncontrolled epilepsy
- Open wounds
- Acute infections
- Neurological disorders
- Orthopedic conditions affecting exercise participation in pool and land
- Cardio-respiratory conditions affecting exercise participation in pool and land.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Water based perturbation exercise group
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. |
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.
Other Names:
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Active Comparator: Land based perturbation exercise group
All procedures were followed similar to Water based perturbation exercise group except perturbation based exercises were provided in land.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Low back pain
Time Frame: 6 weeks
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Visual Analogue Scale (VAS) was used where 0 indicates no pain and 10 indicate extremely painful.
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6 weeks
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Disability caused by the chronic low back pain
Time Frame: 6 weeks
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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.
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6 weeks
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Physical activity associated fear avoidance behavior
Time Frame: 6 weeks
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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.
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6 weeks
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Fall risk
Time Frame: 6 weeks
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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.
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of perceived exertion
Time Frame: 6 weeks
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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.
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6 weeks
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Impairment - Straight Leg Raise as hip joint range of motion
Time Frame: 6 weeks
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Straight leg raise range of motion was measured to identify the level of impairment and to confirm any leg pain associated with back pain
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6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INT/COHS/UG/012-2019
- COHS_UG_Research_6122017 (Other Identifier: GMU Ethical commitee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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