NCT05973695

Brief Summary

Gluteal amnesia is a "condition" where the individual is believed to have lost the ability to contract their gluteal muscles - generally the gluteus maximus, though some report it as the gluteus medius. This can take many different names, such as "dead butt", "sleeping glutes", or glutes that are "turned off".Since the gluteus medius normally helps stabilize the pelvis, gluteal amnesia can lead to lower back pain and hip pain, as well as knee and ankle issues, as the body tries to compensate for the imbalance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

June 27, 2023

Last Update Submit

April 29, 2024

Conditions

Keywords

gluteal weaknessdisabilitypaingluteal amnesia

Outcome Measures

Primary Outcomes (3)

  • Numerical Pain Rating scale (NPRS)

    The numerical Pain Rating scale (NPRS) assesses the pain in the gluteal region. Pain is assessed using a Numeric pain rating (NPRS). The scale ranges from 0 to 10. 0 indicates "no pain", and 10 indicates "worst Pain. mild pain score 1 to 3 moderate pain score 4 to 7 severe pain score with interference with functioning. 8 to 10

    upto 4 weeks

  • Oswestry disability score

    Oswestry Disability score is used to measure low back disability. Each ten item is scored from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability caused by LBP. Oswestry Disability Index will evaluate disability for disability. This questionnaire will be used to assess disability. It comprises 10 items, 7 related to daily activities, 2 related to pain, and 1 related to concentration. Each item scores from 0 to 5. The total score is expressed as a percentage with higher scores related to more significant disability

    upto 4 weeks

  • Quality of Life EQ-5D

    EQ-5D Health-Related Quality of Life Question checked the quality of life of the patients. Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each with five severity levels described by statements appropriate to that dimension. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). This is used to obtain a respondent's stated preference values, not to record their own health state.

    upto 4 weeks

Study Arms (2)

Group A: Clamshell Exercise

ACTIVE COMPARATOR

Group A will be treated with baseline treatment and clamshell exercises. Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions.

Other: clamshell exercise

Group B: Gluteal Bridge exercise

ACTIVE COMPARATOR

Group B will be treated with baseline treatment and Gluteal Bridge exercises. Start flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive down through your feet and push your hips up. You should feel this variation fatiguing the outer portion of your thighs. Make sure you keep your knees over your toes throughout the entire movement. Don't let them move forward over the toes. In a controlled motion, let your hips sink back down toward the ground. This completes 1 repetition. Perform 3 sets of 15 repetitions, or 3 rounds of a 30-second hold.

Other: Gluteal Bridge exercises

Interventions

For clamshell exercises, Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions

Group A: Clamshell Exercise

Start flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive d

Group B: Gluteal Bridge exercise

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female between the ages of 20 to 40 years
  • Prolonged sitting hours \>4 hours.
  • Examination- Symptoms provoked by low back movement.
  • Positive Gluteal strength test
  • Positive SLR for hamstring tightness
  • Positive Thomas test for Rectus femoris tightness.

You may not qualify if:

  • Osteoporosis
  • Malignancy
  • Vertebral fractures
  • Pervious or scheduled surgery
  • Trauma
  • Pregnancy
  • Psychological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Samrood Akram, Mphil

    Riphah International University,Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

August 3, 2023

Study Start

October 5, 2023

Primary Completion

March 8, 2024

Study Completion

March 10, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations