NCT07892066

Brief Summary

This study aims to compare the sequential effects of Instrument-Assisted Soft Tissue Mobilization (IASTM) and Transverse Oscillatory Pressure (TOP), with and without Directional Dynamic Cupping, in patients with thoracic back pain. The study will evaluate the effectiveness of these treatment approaches in reducing pain, improving functional ability, and minimizing disability during daily activities.

Trial Health

63
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Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress6%
Oct 2026Dec 2026

First Submitted

Initial submission to the registry

October 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

October 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

2 months

First QC Date

October 17, 2026

Last Update Submit

October 17, 2026

Conditions

Keywords

Instrument-assisted soft tissue mobilizationManual therapyFunctional disabilityDirectional dynamic cuppingTransverse oscillatory pressure

Outcome Measures

Primary Outcomes (3)

  • Numerical Pain Rating Scale

    The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs).

    Baseline , after 2 weeks and 4 weeks post treatment

  • FUNCTION RATING INDEX

    The Functional Rating Index (FRI) consists of 10 items: pain intensity, pain frequency, sleep, personal care, travel, work, leisure activities, lifting, walking, and standing. Two items assess pain characteristics, while eight assess spinal functional limitations in daily activities. Each item is scored from 0 (no pain/full function) to 4 (maximum pain/total disability), with higher scores indicating greater disability.

    Baseline , after 2 weeks and 4 weeks post treatment

  • BUBBLE INCLINOMETER

    Lumbar range of motion (ROM) will be measured in standing using bubble inclinometers, with S1 and T12 as reference points for flexion and extension, and T12 for lateral flexion. Two inclinometers will assess forward flexion, while one will assess extension and lateral flexion; actual flexion and extension ROM will be calculated by subtracting the lower inclinometer reading from the upper reading.

    Baseline , after 2 weeks and 4 weeks post treatment

Study Arms (2)

Instrument assisted soft tissue (IASTM), Transvers oscillatory pressure (TOP)

ACTIVE COMPARATOR
Other: Instrument assisted soft tissue (IASTM), Transvers oscillatory pressure (TOP)

Instrument assisted soft tissue, Transvers oscillatory pressure and Directional dynamic cupping

EXPERIMENTAL
Other: Instrument assisted soft tissue (IASTM), Transvers oscillatory pressure (TOP) and Directional dynamic cupping

Interventions

Participants will receive Instrument-Assisted Soft Tissue Mobilization (IASTM) and Transverse Oscillatory Pressure (TOP) in sitting or prone positions, combined with alternating 10-second resisted isometric trunk flexion-extension contractions. Conventional therapy includes a hot pack for 10 minutes and muscle stretching (10 repetitions, 30-second hold each).

Instrument assisted soft tissue (IASTM), Transvers oscillatory pressure (TOP)

Participants will receive a moist hot pack over the thoracic region for 10-15 minutes, followed by IASTM using the Graston tool for 5-8 minutes. Transverse Oscillatory Pressure (TOP) will be applied for 3-5 minutes per affected segment, according to patient tolerance. Directional Dynamic Cupping will then be performed over the thoracic paraspinal muscles for 5-10 minutes with controlled suction and gliding movements.

Instrument assisted soft tissue, Transvers oscillatory pressure and Directional dynamic cupping

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-specific chronic thoracic back pain patients aged between 25 to 45 Both genders. Mild to moderate thoracic back pain with NPRS pain score value of between 3/10 6/10. Pain from at least past three months (12 weeks). Pain localized to thoracic region T1-T12, no radiating pain Willing to provide informed consent and attend all sessions

You may not qualify if:

  • Pathological conditions or diagnosed with disk herniation, spinal stenosis, spondylolisthesis, and spondylitis and other medical illnesses such as tumor, lungs disease, and visceral disease or any other red flag condition Referred pain: cervical/lumbar radiculopathy History of cardio-respiratory disease, thoracic surgery, or ribs fracture fixation surgery \<6 months Bleeding disorder/anticoagulant use, skin infection, hypersensitivity at treatment area Pregnancy, BMI \>35.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Management & Technology

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

MeSH Terms

Conditions

Back Pain

Interventions

Abortion, Induced

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 17, 2026

First Posted

October 23, 2026

Study Start

October 20, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share

The result data collected de-identified individual participant data will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Six months after the publication of the manuscript.
Access Criteria
Data can be requested from the corresponding author.

Locations