NCT05460949

Brief Summary

Hyper lordosis is a condition in which there is an excessive spine curvature in the lower back. Hyper lordosis is a very common symptom. It occurs in high-income, middle-income, and low-income countries and all age groups from children to the elderly population Only a small proportion of people have a well understood pathological cause-eg, a vertebral fracture, malignancy, or infection. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greatest risk of reporting low back pain.Hyper lordosis creates a characteristic C-shaped curve in the lower back, or lumbar region, where the spine curves inward just above the buttocks. It often occurs as a result of poor posture or a lack of exercise. Hyperlordosis can cause muscle tightening and stiffness in the lower back. It can also damage the spine and soft tissues in the lumbar region. Hyperlordosis leads to excessive curvature of the spine in the lower back, causing the abdomen and buttocks to appear more prominent in profile view. People with hyperlordosis may experience mild to severe lower back pain, which may worsen with movement. Various conservative treatments are used to treat hyperlordosis and low back pain due to hyperlordosis. Most commonly used are the manual therapy techniques that employ William's protocol and hold relax stretching of iliopsoas muscle at lumbar spine. This study will be randomized control trial used to compare the effects of William protocol and hold relax stretching of iliopsoas muscle in subjects with hyperlordosis and low back pain. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre assessment will be done using LUMBAR SPINE QUESTIONNAIRE as subjective measurements and NPRS as objective measurements. Subjects in one group will be treated using William's protocol and the other one will be treated with hold relax stretching of iliopsoas muscle. Each subject will receive 08 treatment sessions with 02 treatment sessions per week. Post treatment reading for NPRS and lumbar spine questionnaire will be recorded after every week.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

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

January 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

July 14, 2022

Last Update Submit

September 5, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • pain assessment

    The NRS for pain is a unidimensional measure of pain intensity in adults including those with chronic pain due to rheumatic diseases. Although various iterations exist, the most commonly used is the 11-item NRS

    8 weeks

  • lordatic angle

    2- Flexicurve ruler: The angle of lumbar lordosis will be measured with a flexible ruler. The subject remained in the normal standing posture while lordatic angle was measured

    8 weeks

  • low back pain

    3- Lumbar spine questionnaire (LSQ): It is used for the assessment of low back pain. It contains various items and patients will be asked relevant questions and answers will be noted and written

    8 weeks

Study Arms (2)

HOLD RELAX STRETCHING OF ILIOPSOAS

EXPERIMENTAL

10-second isometric contraction of iliopsoas muscle (HR), 10-second rest, 20-second static stretch, 5 repetitions. The stretching exercise was performed 2 times a week for 8 weeks.

Other: HOLD RELAX STRETCHING OF ILIOPSOAS

• WILLIAM'S PROTOCOL

EXPERIMENTAL

* Pelvic tilt * Single Knee to chest * Double knee to chest * Partial sit-up * Hamstring stretch * Hip Flexor stretch * Squat * Each group performed special trainings for 8 weeks, 2 sessions per week; each session took about 1 hour. Duration of each exercise was 8 to 10 seconds in each set. Protocols were started with 1 set of 10 repetitions at starting baseline and by improving performance and patients' compatibility with trainings, all eventually finished with 3 sets of 20 repetitions at the end of protocols.

Other: WILLIAM'S PROTOCOL

Interventions

10 second isometric contraction of iliopsoas muscle (HR), 10-second rest, 20 second static stretch, 5 repetitions. • The stretching exercise was performed 2 times a week for 8 weeks. 10 second isometric contraction of iliopsoas muscle (HR), 10-second rest, 20 second static stretch, 5 repetitions. The stretching exercise was performed 2 times a week for 8 weeks.

HOLD RELAX STRETCHING OF ILIOPSOAS

Pelvic tilt Single Knee to chest Double knee to chest Partial sit-up Hamstring stretch Hip Flexor stretch Squat Each group performed special trainings for 8 weeks, 2 sessions per week; each session took about 1 hour. Duration of each exercise was 8 to 10 seconds in each set. Protocols were started with 1 set of 10 repetitions at starting baseline and by improving performance and patients' compatibility with trainings, all eventually finished with 3 sets of 20 repetitions at the end of protocols.

• WILLIAM'S PROTOCOL

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 21-40 years
  • Hyperlordosis Angle
  • Females having increased lordotic curve
  • Pain perceived anywhere in the region of lumbar spine from L1 to l5.
  • Limitation of lumbar spine range of motion.

You may not qualify if:

  • Any red flags including tumors, fractures.
  • Spinal canal stenosis
  • Rheumatoid arthritis
  • Osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

MeSH Terms

Conditions

Swayback

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesSheep DiseasesAnimal Diseases

Study Officials

  • Hafiza Mehjabeen, MSWHPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

July 14, 2022

First Posted

July 15, 2022

Study Start

January 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations