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Water Versus Land Based Perturbation Exercises in Elderly Participants With Back Pain

Primary Purpose

Back Pain, Back Pain With Radiation, Back Pain Without Radiation

Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Exercises
Sponsored by
Gulf Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Back Pain, Old Age, Exercises, Hydrotherapy, Rehabilitation

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gulf Medical University, Thumbay Physical Therapy and Rehabiliation Hospital, Thumbay University Hospital
  • Gulf Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Water based perturbation exercise group

Land based perturbation exercise group

Arm Description

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.

All procedures were followed similar to Water based perturbation exercise group except perturbation based exercises were provided in land.

Outcomes

Primary Outcome Measures

Low back pain
Visual Analogue Scale (VAS) was used where 0 indicates no pain and 10 indicate extremely painful.
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.
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.
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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
October 13, 2022
Last Updated
April 12, 2023
Sponsor
Gulf Medical University
Collaborators
Srinivas University
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1. Study Identification

Unique Protocol Identification Number
NCT05585294
Brief Title
Water Versus Land Based Perturbation Exercises in Elderly Participants With Back Pain
Official Title
The Effectiveness of Perturbation Exercises in Elderly Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulf Medical University
Collaborators
Srinivas University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Back Pain With Radiation, Back Pain Without Radiation, Back Pain Lower Back Chronic
Keywords
Back Pain, Old Age, Exercises, Hydrotherapy, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pre and post outcomes comparison after clinical intervention
Masking
Care ProviderOutcomes Assessor
Masking Description
Outcome assessor unaware of what care was provided, and care was provided by other providers. Possibility of sequential trail is considered. The value of p will be adjusted depending the number of analysis made and stopping rule will be followed.
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water based perturbation exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Land based perturbation exercise group
Arm Type
Active Comparator
Arm Description
All procedures were followed similar to Water based perturbation exercise group except perturbation based exercises were provided in land.
Intervention Type
Behavioral
Intervention Name(s)
Exercises
Other Intervention Name(s)
Mckenzie extension exercise, mobilization and spinal lumbar traction therapy tailored based on TBC system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Low back pain
Description
Visual Analogue Scale (VAS) was used where 0 indicates no pain and 10 indicate extremely painful.
Time Frame
6 weeks
Title
Disability caused by the chronic low back pain
Description
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.
Time Frame
6 weeks
Title
Physical activity associated fear avoidance behavior
Description
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.
Time Frame
6 weeks
Title
Fall risk
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Rate of perceived exertion
Description
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.
Time Frame
6 weeks
Title
Impairment - Straight Leg Raise as hip joint range of motion
Description
Straight leg raise range of motion was measured to identify the level of impairment and to confirm any leg pain associated with back pain
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Ramprasad Muthukrishnan, Ph.D
Organizational Affiliation
Gulf Medical Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulf Medical University, Thumbay Physical Therapy and Rehabiliation Hospital, Thumbay University Hospital
City
Ajman
Country
United Arab Emirates
Facility Name
Gulf Medical University
City
Ajman
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data is available and processed final.
IPD Sharing Access Criteria
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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Water Versus Land Based Perturbation Exercises in Elderly Participants With Back Pain

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