NCT07834190

Brief Summary

This randomized controlled trial compares two manual therapy interventions for adults with thoracic spine hypo mobility. Fifty-two participants are randomly allocated by coin toss to one of two equal groups (n = 26 each). Both groups first receive an identical preparatory protocol consisting of a combined session of TENS (transcutaneous electrical nerve stimulation) and hot pack application for 20 minutes, intended to reduce baseline pain and prepare the tissue for mobilization. Following this preparatory phase, Group A receives Maitland oscillatory mobilization, applied as small and large amplitude rhythmic passive movements directed at the spinous processes of the thoracic vertebrae (T1-T12). This is delivered as 3 sets of 15 repetitions, using Grades I-II to reduce pain and Grades III-IV to increase range of motion once pain has eased. Group B receives Kaltenborn sustained mobilization, which applies a slower, held stretch to the same thoracic spinous processes. This consists of 3 repetitions of a 30-60 second sustained hold, using Grades I-II for pain relief and Grade III (stretch beyond the point of restriction) to improve mobility once pain has decreased. Both interventions target the same spinal segments and are delivered in a single session by the same non-blinded protocol. Immediately after treatment, outcomes are reassessed: pain via the Numeric Pain Rating Scale (NPRS) and thoracic range of motion (flexion, extension, and right/left rotation in a lumbar-locked position) via a smartphone inclinometer application. The trial thus isolates the difference between a rhythmic, oscillatory mobilization technique and a slower, sustained-hold mobilization technique, allowing a direct immediate-effect comparison of the two manual therapy approaches for thoracic hypo mobility.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress69%
Feb 2026Jan 2027

Study Start

First participant enrolled

February 13, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2027

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 16, 2026

Last Update Submit

September 16, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Thoracic Pain (T1-T12)

    Numeric Pain Rating Scale is an 11 point pain rating scale from 0-10 where 0 represents no pain and 10 represents the worst pain imaginable.

    Before and right after immediately the intervention.

  • Thoracic Range of Motion

    Smartphone inclinometer will be used to assess the range of motion of the thoracic spine. The baseline assessment will establish each participant's pre-intervention ROM values, which will serve as the reference (baseline) values for subsequent comparison, changes in the thoracic ROM from baseline to post-intervention will be determined within each group.

    Before and immediately after the intervention is applied.

Study Arms (2)

Group A oscillatory mobilizations

EXPERIMENTAL
Procedure: oscillatory mobilization

Group B sustained mobilizations

EXPERIMENTAL
Procedure: Sustained Mobilizations

Interventions

Group A first receives a combined 20-minute session of TENS (transcutaneous electrical nerve stimulation) and hot pack application to reduce baseline pain. This is followed by Maitland oscillatory mobilization, applied manually to the spinous processes of the thoracic vertebrae (T1-T12), delivered as 3 sets of 15 repetitions. Treatment begins with Grade I-II oscillations, which are small- to large-amplitude rhythmic movements performed within the pain-free range to reduce pain through activation of inhibitory pain-gate mechanisms and increased joint fluid viscosity. Once pain decreases, Grade III-IV oscillations are introduced, involving larger-amplitude movement up to end-range resistance, to improve thoracic range of motion. All mobilizations are performed by the treating therapist in a single session.

Group A oscillatory mobilizations

Group B first receives the same combined 20-minute session of TENS and hot pack application to reduce baseline pain. This is followed by Kaltenborn sustained mobilization, applied manually to the spinous processes of the thoracic vertebrae (T1-T12), delivered as 3 repetitions of a 30-60 second sustained hold. Treatment begins with Grade I-II holds, involving slight distraction and taking up slack to the point of restriction, aimed at reducing pain and stimulating Type II mechanoreceptors. Once pain decreases, a Grade III sustained stretch is applied, held beyond the point of restriction in the range of motion, to improve thoracic mobility. All mobilizations are performed by the treating therapist in a single session.

Group B sustained mobilizations

Eligibility Criteria

Age25 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adults (ages 25-44)
  • both male and female
  • localized thoracic pain (T1-T12)
  • Pain intensity of ≥ 3/10 on NPRS at baseline
  • reduced segmental mobility on PA spring test compared to adjacent segments
  • positive thoracic schober's test, indicating reduced thoracic mobility

You may not qualify if:

  • recent surgery (at least6 months ago) Diagnosed diseases
  • systemic diseases (e.g. RA, SLE etc)
  • spinal surgery
  • ankylosing spondylitis
  • recent history of fracture
  • scoliosis
  • spondylolisthesis and spondylosis
  • spinal TB
  • spinal stenosis
  • degenerative disc
  • fibromyalgia
  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, Punjab Province, 46000, Pakistan

RECRUITING

Central Study Contacts

Zaha Asif, DPT

CONTACT

Muhammad Furqan Hassan, MS-OMPT

CONTACT

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

September 16, 2026

First Posted

September 22, 2026

Study Start

February 13, 2026

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

January 18, 2027

Last Updated

September 22, 2026

Record last verified: 2026-09

Locations