NCT06963658

Brief Summary

Randomized control trial to examine the immediate effect of isometric exercise on pressure pain threshold (PPT) in adults with chronic low back pain. The secondary aim of this study was to investigate the acute effects of isometric exercise on clinical pain intensity.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 13, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

March 13, 2025

Last Update Submit

August 27, 2025

Conditions

Keywords

pain sensitivityisometric exerciselow back pain

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is pain sensitivity

    Pain sensitivity was assessed via pressure pain threshold (PPT) using a standard procedure. The PPT was assessed by a digital pressure algometer (Wagner digital force Ten FDX 25 with 1 cm 2 rubber tip).This instrument has been widely utilized in various studies and has been shown to be valid and reliable in assessing PPT among people with musculoskeletal pain. If post intervention PPT was higher than pre-intervention value, this indicated that pain sensitivity decreased, suggesting exercise induced hypoalgesia occurred. If post-intervention PPT was lower than pre-intervention PPT, this indicates that pain sensitivity increased, suggesting that exercise induced hyperalgesia occurred.

    pre- and immediately post-intervention

Secondary Outcomes (1)

  • The secondary outcome is the pain intensity in the lower back

    pre- and immediately post-intervention

Study Arms (3)

Multiple repetition isometric wall squat

EXPERIMENTAL

Participants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold.

Other: Multiple repetition isometric wall squat

Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold

EXPERIMENTAL

Participants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold. Immediately post 60 second rest, Determine the participant's maximum angle using the double leg lowering test from supine position let the participant with both legs straightened before lifting the posterior hip, lowering the legs to a specific angle. Turn on the stopwatch. Hold the position near--maximally, try to achieve on (IES=9/10) and hold for the longest duration. They should reach 4 minutes for 3 repetition with 30 seconds rest between repetition

Other: Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold

Control quiet seated rest

EXPERIMENTAL

The CON group served as the control group and did not perform any exercise. Participants were instructed to sit quietly in a standard height stationary clinical room patient chair for the entire eight minutes.

Other: Control quiet seated rest

Interventions

Participants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold.

Multiple repetition isometric wall squat

Participants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold. Immediately post 60 second rest, Determine the participant's maximum angle using the double leg lowering test from supine position let the participant with both legs straightened before lifting the posterior hip, lowering the legs to a specific angle. Turn on the stopwatch. Hold the position near--maximally, try to achieve on (IES=9/10) and hold for the longest duration. They should reach 4 minutes for 3 repetition with 30 seconds rest between repetition

Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold

The control group served as the control group and did not perform any exercise. Participants were instructed to sit quietly in a standard height stationary clinical room patient chair for the entire eight minutes.

Control quiet seated rest

Eligibility Criteria

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

You may qualify if:

  • participants aged ≥18 years or older
  • participant diagnosed with non-specific chronic lower back pain (\> 12 weeks)

You may not qualify if:

  • pregnant women 2- lactating women for one or less than one year post-natal. 3- any certain medical conditions that could interfere with physical activity, including:
  • uncontrolled diabetes
  • cardiovascular problem
  • orthopedic impairments
  • balance problems. 4-serious spinal pathologies :
  • infection
  • fractures
  • tumors
  • inflammatory diseases like ankylosing spondylitis 5- neurological compromise,
  • spinal nerve compromise
  • cauda equina syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdullah Hospital in bisha

Bisha, 'Asir Region, 67714, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Asma A Alqahtani, B.S.C

CONTACT

Hosam A Alzahrani, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 13, 2025

First Posted

May 9, 2025

Study Start

August 1, 2025

Primary Completion

October 1, 2025

Study Completion

January 1, 2026

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations