Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
NCT07921784, Not applicable, Not yet recruiting, Imam Abdulrahman Bin Faisal University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain | ClinicalTrials.gov |
| NCT number | NCT07921784 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 66 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Imam Abdulrahman Bin Faisal University | ClinicalTrials.gov |
| Conditions | Low Back Pain, Trigger Point Pain, Myofascial | ClinicalTrials.gov |
| Interventions | Instrument Assisted Soft Tissue Mobilization, Deep Friction Massage, Sham Instrument-Assisted Soft Tissue Mobilization | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | pain | Outcome measures will be collected at baseline before treatment initiation (T0), immediately after the first intervention session (T1), and at Week 4 following completion of the intervention period (T2). | The assessment of pain intensity was done with the help of Visual Analog Scale (VAS), which is an accepted and proven instrument to measure pain in musculoskeletal diseases. The VAS was comprised of a horizontal line that had a length of 100 mm between two points, labeled "no pain" and "worst pain imaginable." Patients had to indicate how severe their pain was by marking the scale. Scores were calculated by determining the distance from the "no pain" point to the mark, expressed in millimeters. High scores indicated more severe pain sensations. The VAS scale is a reliable and valid measurement tool, and the minimal clinical difference is estimated at 12 mm | ClinicalTrials.gov |
| Primary | Disability | Outcome measures will be collected at baseline before treatment initiation (T0), and at Week 4 following completion of the intervention period (T2). | Oswestry Disability Index (ODI) was used as the measure to determine the level of physical disability experienced due to CLBP. ODI refers to a reliable and valid self administered questionnaire consisting of 10 items covering various aspects of daily activity performance on a 0-to-5-point scale | ClinicalTrials.gov |
| Primary | Range of motion | Outcome measures will be collected at baseline before treatment initiation (T0), and at Week 4 following completion of the intervention period (T2). | Lumbar range of motion (ROM) will be assessed using Bubble inclinometer, a non invasive instrument widely used to quantify spinal mobility. Measurements will be obtained for lumbar flexion, extension, and lateral flexion using standardized anatomical landmarks. The T12 and S1 spinous processes will be used as reference points for flexion and extension measurements, while the T12 spinous process will serve as the reference point for lateral flexion assessment. | ClinicalTrials.gov |
| Primary | Neuromuscular function | Outcome measures will be collected at baseline before treatment initiation (T0), and at Week 4 following completion of the intervention period (T2). | Neuromuscular functional performance will be assessed using surface electromyography (sEMG) to evaluate paraspinal muscle activation during lumbar movement. Bilateral muscle activity of the thoracic erector spinae (TES), lumbar erector spinae (LES), and lumbar multifidus (LMU) will be recorded using a wireless surface electromyography system (Trigno™ Wireless EMG System, Delsys Inc., Natick, Massachusetts, USA). | ClinicalTrials.gov |
| Secondary | Pain pressure threshold | Outcome measures will be collected at baseline before treatment initiation (T0), immediately after the first intervention session (T1), and at Week 4 following completion of the intervention period (T2). | The Pain pressure threshold test was performed using the hand-held digital algometer, which is a valid and reliable method of pain sensitivity quantification. The examination was conducted bilaterally on the lumbar paraspinal muscles using the Wagner FDX-25 digital algometer, with the application rate set to a constant 50 kPa per second. | ClinicalTrials.gov |
| Secondary | Psychological status | Outcome measures will be collected at baseline before treatment initiation (T0), and at Week 4 following completion of the intervention period (T2). | Psychological status include depression is more prevalent among individuals with chronic low back pain and is associated with greater pain intensity, disability, medication use, and unemployment, highlighting the importance of routine depression screening in this population \[39\]. Hospital Anxiety and Depression Scale (HADS), which is a tool used to assess psychological status, particularly anxiety and depression, was applied in the current study. HADS Arabic version consists of 14 items that are categorized into two domains: anxiety and depression, scored on a scale from 0 to 3. Scores that are higher indicate more psychological distress, while a score above 11 signifies clinical importance of the symptoms. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)