NCT06045182

Brief Summary

Sacroiliac joint (SIJ) dysfunction is known as an important contributing factor in lower back pain. Pain and stiffness experienced from the sacroiliac joint in the SI region (hips/groins or may spread to lower extremity) is referred as SIJ dysfunction.Physiotherapists have a wide range of options in managing SIJD including Manipulation, Kinesiotaping, Muscle Energy Technique (MET), McKenzie, Maitland's mobilization, and Mulligan's mobilization. So far studies have shown the efficacy of different treatment tools in combination or in isolation. Likewise, researchers have also studied the effect of piriformis stretch in combination with other exercises on sacroiliac joint pain. However, there is very limited literature available on the cumulative effect of piriformis stretch along with mobilization maneuvers on pain and disability in patient with SIJ dysfunction.Since piriformis is one of the most important muscles involved in stabilization of SI joint and a major source of SI dysfunction, hence the current study is designed to investigate the additional effects of piriformis stretch with manual therapy in the management of sacroiliac joint dysfunction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 30, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

September 13, 2023

Last Update Submit

September 13, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale

    1 week

  • Disability level of participant

    Disability will be assessed using Oswestry low back disability Index. A higher score indicates more disability

    1 week

Study Arms (2)

Group A (Maitland mobalizations )

ACTIVE COMPARATOR

Patients in this group will receive Maitland mobilizations along with hot pack and TENS for pain and disability. A total of 3 sessions would be conducted over a period of 1 week.

Procedure: Maitland mobilizationProcedure: Electrotherapy

Group B (Maitland Moblizations along with piriformis stretch)

EXPERIMENTAL

Patients will receive Maitland mobilizations along with hot pack and TENs and additional stretch of piriformis muscle is given. A total of 3 sessions would be conducted over a period of 1 week.

Procedure: Maitland mobilizationProcedure: Piriformis stretchProcedure: Electrotherapy

Interventions

Participants in this group will be first given hot pack and TENS for 10 min. Then they will be given Maitland Mobilizations (10 oscillations total of 3 sets )with 10 sec rest in between. Mobilization will be Unilateral or central based on the patient condition and Intensity of Mobilizations increases as per patient tolerance in 2nd and 3rd session.

Group A (Maitland mobalizations )Group B (Maitland Moblizations along with piriformis stretch)

Piriformis stretch will be given to this group. In first session piriformis stretch will be given for 10 sec with 10-second resting time in between with, 7 rep total of 1 set. For the 2nd and 3rd session repetitions will be increase to 8 and 10 respectively.

Group B (Maitland Moblizations along with piriformis stretch)

Hot pack and TENS for 10 min

Group A (Maitland mobalizations )Group B (Maitland Moblizations along with piriformis stretch)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults (both male and female) aged 18-45 years experiencing sacroiliac joint pain
  • Patients fulfilling the diagnostic criteria, recommended by the International Association for the Study of Pain (IASP).(13)
  • Those with \> 4 score on Numeric pain rating scale for the sacroiliac pain
  • Using no other pain killers or non steroidal anti-inflammatory drugs during the therapy

You may not qualify if:

  • Individuals suffering from pain due to other conditions (low back pain, hip pathology, hip osteoarthritis, cognitive disorders, radicular pain, ankylosing spondylitis, coccydynia)
  • Patients with piriformis syndrome.
  • SIJ pain due to other causes such as fractures, tumors and trauma.
  • Pregnant females
  • Those patients who have received any surgical treatment for SIJ dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Interventions

Electric Stimulation Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Anum Sadiq, DPT,MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. One group will receive maitland mobalizations and the second will receive maitland mobalization along with piriformis stretch. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

August 30, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations