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

Not Applicable

Completed

• Conditions: Back Pain; Back Pain Without Radiation; Back Pain With Radiation; Back Pain Lower Back Chronic
• Interventions: Behavioral: Exercises

• Registration Number: NCT05585294
• Lead Sponsor: Gulf Medical University

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.

Study Timeline

• Study Start: 2019-12-21
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-15
• Study First Posted: 2022-10-18
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water based perturbation exercise group	Exercises	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.
Land based perturbation exercise group	Exercises	All procedures were followed similar to Water based perturbation exercise group except perturbation based exercises were provided in land.

Primary Outcome Measures

Name	Time	Method
Fall risk	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.
Low back pain	6 weeks	Visual Analogue Scale (VAS) was used where 0 indicates no pain and 10 indicate extremely painful.
Physical activity associated fear avoidance behavior	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.
Disability caused by the chronic low back pain	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.

Secondary Outcome Measures

Name	Time	Method
Rate of perceived exertion	6 weeks	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	6 weeks	Straight leg raise range of motion was measured to identify the level of impairment and to confirm any leg pain associated with back pain

Trial Locations

Locations (2)

Gulf Medical University, Thumbay Physical Therapy and Rehabiliation Hospital, Thumbay University Hospital; 🇦🇪 Ajman, United Arab Emirates

Gulf Medical University; 🇦🇪 Ajman, United Arab Emirates