NCT06737783

Brief Summary

The aim of this randomized clinical trial is to find the effect of thoracic mobility exercises on thoracic hyper kyphosis and hamstring flexibility with tibiofemoral arthritis patients on reducing hyper kyphotic posture, knee pain and improving flexibility of hamstring muscles.

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 Dec 2024

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

Study Start

First participant enrolled

December 3, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

December 12, 2024

Last Update Submit

August 18, 2025

Conditions

Keywords

Thoracic hyperkyphosisHamstring flexibilitythoracic mobility exercises

Outcome Measures

Primary Outcomes (3)

  • Active knee extension test (Goniometer)

    Active knee extension (AKE) test was to measure hamstring flexibility. The participants lay in the supine/prone position with the tested hip flexed 90°, knee flexed 90° and were asked to extend the knee as much as possible until they felt strong resistance. Ensure Lumbar spine should be in neutral position. Axis of Goniometer will be placed on Lateral femoral condyle of femur. While moving and stationary arm on lateral aspect of midline of femur and fibula. Complete knee extension was 0° shows optimal flexibility and any lack of knee extension was measured with a universal goniometer with higher angle 20 degrees indicates poorer flexibility of hamstring muscles.

    4 weeks

  • Visual Analogue scale VAS

    The VAS is a simple bidirectional graphic tool with a 10-cm horizontal line for assessing musculoskeletal pain intensity. Left side of scale represent 0 digit indicates "no pain" and the right end marked with 10 indicates "worst imaginable pain". The participants were asked to draw a vertical mark on the line to represent their level of pain intensity when patient asked to extend knee from flexion and from flexion position to extension. The length from the left end to the vertical mark, made by the participant shown her/his pain intensity

    4 weeks

  • Baseline bubble Inclinometer

    Thoracic kyphosis angle was calculated using a baseline bubble inclinometer, a device used to measure curvature of spine. Inclinometer can measure angles b/w 20 to 60 degrees for thoracic region on wider arc of 180 degree. Participant should be in neutral position. Firstly, an inclinometer was placed over the spinous process of T1 and T2 for measurement (first inclinometer angle). Secondly, another inclinometer was placed over the spinous process of T12 and L1 for angle measurement (second inclinometer angle). The kyphosis angle was taken by taking difference between two measurements. Threshold for hyperkyphotic is greater 40 degrees.

    4 weeks

Study Arms (2)

Thoracic mobility exercises + Conventional therapy

EXPERIMENTAL

mobility exercises comprises of Cat and camel stretch (On hands and knees (supported with knee braces), alternating between arching the back up and dropping it down to stretch thoracic spine), Thoracic rotations in side lying (side lying on the side with knees bent, rotating the upper body to increase thoracic mobility alternatively), Thoracic extension at wall using body weight (Standing with back to wall, gently pushing the upper back into extension while keeping the lower back stable), half kneeling chop thrust (Kneeling on one knee (supported with knee braces), rotating the torso while keeping the pelvis stable to mobilize the thoracic spine) ,Thoracic extension with a foam roller (Lying on the back with foam roller along thoracic spine, rolling gently to extend the thoracic spine in supine position). Adopt these positions with 5 secs hold and 15-20 reps will be performed for 2 sets and 10 reps per set. hold and 15-20 reps will be performed for 2 sets and 10 reps per set.

Other: Thoracic mobility exercises + Conventional therapy

Self myofascial release with foam roller, T6- T7 Maitland mobilization and conventional therapy

ACTIVE COMPARATOR

Hamstring Self myofascial release with foam roller (Sitting with one leg extended, roll the foam roller along the hamstring while applying pressure to tender spots) 3 sets with 30 to 120 secs rolling duration per second for 5 mins T6-T7 grade 3 Maitland mobilization (Lying on the back, the therapist applies a sustained, posterior-to-anterior force on T6-T7 in prone position) 30 repetitions, with 1 min rest between 4 sets for 15 mins. Conventional therapy includes Hot pack/Cold pack + tens = 15 mins, Frequency 80 Hz, Pulse duration: 100 microseconds, Static quads (10 reps, 10 second hold, 2 sets), Active knee flexion and extension ROMs (10 reps, 5 secs hold, 2 sets), Long Axis Knee traction (5 reps, 30 secs hold, 10sec rest in b/w 2 sets), Kaltenborn Knee Glides Ant and Post direction ( 5 reps, 30 secs hold,10 sec rest interval in b/w 2 sets), Calf stretches (10 reps, 5 secs hold , 2 sets).

Other: Self myofascial release with foam roller, T6- T7 Maitland mobilization + Conventional therapy

Interventions

mobility exercises comprises of Cat and camel stretch (On hands and knees (supported with knee braces), alternating between arching the back up and dropping it down to stretch thoracic spine), Thoracic rotations in side lying (side lying on the side with knees bent, rotating the upper body to increase thoracic mobility alternatively), Thoracic extension at wall using body weight (Standing with back to wall, gently pushing the upper back into extension while keeping the lower back stable), half kneeling chop thrust (Kneeling on one knee (supported with knee braces), rotating the torso while keeping the pelvis stable to mobilize the thoracic spine) , Thoracic extension with a foam roller (Lying on the back with foam roller along thoracic spine, rolling gently to extend the thoracic spine in supine position). Adopt these positions with 5 secs hold and 15-20 reps will be performed for 2 sets and 10 reps per set.

Thoracic mobility exercises + Conventional therapy

Hamstring Self myofascial release with foam roller (Sitting with one leg extended, roll the foam roller along the hamstring while applying pressure to tender spots) 3 sets with 30 to 120 secs rolling duration per second for 5 mins T6-T7 grade 3 Maitland mobilization (Lying on the back, the therapist applies a sustained, posterior-to-anterior force on T6-T7 in prone position) 30 repetitions, with 1 min rest between 4 sets for 15 mins. Conventional therapy includes Hot pack/Cold pack + tens = 15 mins, Frequency 80 Hz, Pulse duration: 100 microseconds, Static quads (10 reps, 10 second hold, 2 sets), Active knee flexion and extension ROMs (10 reps, 5 secs hold, 2 sets), Long Axis Knee traction (5 reps, 30 secs hold, 10sec rest in b/w 2 sets), Kaltenborn Knee Glides Ant and Post direction ( 5 reps, 30 secs hold,10 sec rest interval in b/w 2 sets), Calf stretches (10 reps, 5 secs hold , 2 sets).

Self myofascial release with foam roller, T6- T7 Maitland mobilization and conventional therapy

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Thoracic Kyphotic angle \> 40
  • Asymptomatic (no pain symptoms in) thoracic spine
  • Able to stand independently
  • Less than 70 degree Hip Flexion Angle on active SLR, with limited knee extension range more than 20 degree restriction on AKE test
  • Bilateral Hamstring tightness
  • Visual Analogue Scale in targeted Joint Tibiofemoral arthritis \>3 cm
  • Having Osteoarthritis in Tibio femoral Joint, according to KL (Grade 2 and 3)
  • X-rays showing evidence of reduced knee spaced/osteoarthritis symptoms B/L( \>2 year)

You may not qualify if:

  • Muscle/tendon injuries of hamstring
  • Spinal Injuries, scoliosis, tumors and malignancies
  • Any surgery, infection, skin sensitivity, trauma, fracture and fall
  • Involvement in regular flexibility yoga program
  • Patient with intra articular steroidal therapy with in last 6 months
  • Patient unwilling to comply follow up schedule
  • Patient involvement in another interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institue of Rehabilitation Medicine (Nirm)

Islamabad, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Maria khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

December 3, 2024

Primary Completion

June 2, 2025

Study Completion

June 10, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations