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Completed

NCT Number: NCT05585294

Water Versus Land Based Perturbation Exercises in Elderly Participants With 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.

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Key information

Conditions

Back Pain Back Pain Lower Back Chronic Back Pain With Radiation Back Pain Without Radiation Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulf Medical University, Ajman, United Arab Emirates

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exercises

Behavioral

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: Mckenzie extension exercise, mobilization and spinal lumbar traction therapy tailored based on TBC system

Primary outcomes

  1. Low back pain

    Time frame: 6 weeks

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

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Rate of perceived exertion

    Time frame: 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.

  2. Impairment - Straight Leg Raise as hip joint range of motion

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Gulf Medical University

Other

Collaborators

  • Srinivas University

Registry information

Official study title

The Effectiveness of Perturbation Exercises in Elderly Back Pain

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2022
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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