NCT05605444

Brief Summary

The goal of this interventional study is to investigate the effectiveness of an acute bout of exercises on pain sensitivity and clinical pain among adults with knee osteoarthritis. The following question will be answered in this research Q1: Is acute bout of exercise effective in reducing pain sensitivity and intensity among adult with knee osteoarthritis? Participants who agree to participate and sign the informed consent will be randomised to one of three groups: Group 1: Isometric exercise with neutral language and no verbal suggestion consisting of 1 rep of wall squat, 3 min or to volitional fatigue at 100° knee angle;(n=30). Group 2: Isometric exercise with neutral language and no verbal suggestion consisting of 3 reps of wall squat, 3 min or to volitional fatigue at 100°degree knee angle, 30 sec rest between rep, ;(n=30). Group 3 (Control group): true control (do nothing);(n=30).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

October 16, 2022

Last Update Submit

August 27, 2025

Conditions

Keywords

acute bout of exercisePain sensitivityClinical pain

Outcome Measures

Primary Outcomes (1)

  • Pain pressure threshold

    The pain will be measured using digital pressure algometer, FDX®️ (Wagner instrument, Greenwich, USA). All trials will be conducted on forearm, lumbar spine and calf sites. There will be at least 20 sec rest before an individual site is tested again. Two trials will be performed at each site. The raw values of each test will be recorded. Because we are testing repeated times, we will use a marker to mark the location of each test site to ensure consistency in location. Algometer must be positioned perpendicular to the measurement site for all trials.

    Change from pre-intervention (baseline) compared to post-intervention (immediately after session)

Secondary Outcomes (1)

  • Pain intensity

    Change from pre-intervention (baseline) compared to post-intervention (immediately after session)

Study Arms (3)

Isometric exercise-one repetition

EXPERIMENTAL

Isometric exercise consisting of 1 session only. The session will last for around 5 minutes which will include asking the patient to do 1 repetition of wall squat for 3 min or to volitional fatigue at 100° knee angle.

Other: Single bout of exercise

Isometric exercise-three repetitions

EXPERIMENTAL

Isometric exercise consisting of 1 session only. The session will last for around 10 minutes which will include asking the patient to perform 3 repetition of wall squat (each time the exercise will be performed for 3 min or to volitional fatigue at 100°degree knee angle); patient will be given 30 sec rest between repetitions.

Other: Single bout of exercise

Control (no intervention)

NO INTERVENTION

Will not receive any intervention

Interventions

isometric wall squat at a knee joint angle of 100 degrees. Instruct participant to place their back against the wall with feet positioned parallel and spaced shoulder-width apart. Lower themselves down until they reached a knee joint angle of 100 degrees. Measure knee joint angle by placing a goniometer on the lateral epicondyle of the knee, in line with the femur whilst the anchor arm was in line with the lateral malleolus.

Isometric exercise-one repetitionIsometric exercise-three repetitions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older.
  • Diagnosed by surgeon using radiological imaging and clinical decision with unilateral or bilateral symptomatic knee OA.
  • Have chronic knee pain for three months and more (with average VAS in the last week \>= 3/10).
  • Able to perform physical therapy exercise.

You may not qualify if:

  • Pregnancy.
  • Severe musculoskeletal or neuromuscular disorders or any disease that prevent performing exercises.
  • Uncontrolled diabetes.
  • Knee or lower limb surgery.
  • Sensations problems.
  • Orthopedic impairment (e.g., sever deformities, ligament injuries, balance problems and fractures in lower limb in the last 6 months).
  • Any contraindication to exercise preventing them from performing exercises as per the "American College of Sports Medicine" guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King AbdulAziz Hospital and King Faisal Hospital

Mecca, Mecca Region, Saudi Arabia

Location

Related Publications (1)

  • Zabarmawi J, Miller CT, Owen PJ, Mundell NL, Meny A, Aldhafri S, Banjar R, Alzahrani H. Efficacy of an acute bout of isometric wall squat exercise on pain sensitivity and clinical pain intensity in adults with knee osteoarthritis: a randomised controlled trial in outpatient physiotherapy clinics in Saudi Arabia. BMJ Open. 2025 Dec 11;15(12):e103756. doi: 10.1136/bmjopen-2025-103756.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Hosam Alzahrani, PhD

    Taif University, College of Applied Medical Science, Physical Therapy Department, TAIF, SAUDI ARABIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 16, 2022

First Posted

November 4, 2022

Study Start

November 15, 2022

Primary Completion

April 25, 2023

Study Completion

May 20, 2023

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations