NCT06447493

Brief Summary

The purpose of this study is to see the impact of a modified Spencer's technique on tissue stiffness, mobility, and blood flow of the shoulder joint. Spencer's technique is a well-known osteopathic manipulative treatment (OMT) that is common for treating adhesive capsulitis and is believed to help blood flow. There are studies that look at the clinical effects of the technique and/or compare it to other techniques; however, measuring the extent to which Spencer's technique, or this modified technique, improves tissue stiffness and blood flow has never been written in the literature. This study will serve as a proof of concept that this technique improves tissue stiffness, blood flow, and mobility of the shoulder join as well as the nearby areas. Using ultrasound, the investigators will measure tissue stiffness and blood flow and will analyze the mobility of the shoulder joint using a Vicon motion capture system.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Aug 2023

Typical duration for not_applicable

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 Progress94%
Aug 2023Jul 2026

Study Start

First participant enrolled

August 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Expected
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

June 3, 2024

Last Update Submit

August 4, 2025

Conditions

Keywords

Osteopathic PhysiciansShoulderDiagnostic ImagingMotion CaptureRange of Motion, ArticularBlood CirculationPain

Outcome Measures

Primary Outcomes (4)

  • Muscle Stiffness

    Using Shear Wave Elastography to measure muscle stiffness (kPa) of the supraspinatus, infraspinatus, posterior shoulder capsule, and coracoacromial ligament.

    Day 1 Pre, Day 1 Post, Day 2

  • Shoulder Mobility

    Using Vicon motion capture system to calculate landmark coordinates and using morphometric canonical variate analysis to analyze mobility changes.

    Day 1 Pre, Day 1 Post, Day 2

  • Microvascular/capillary blood flow

    Using ultrasound to capture blood flow of the supraspinatus, infraspinatus, posterior shoulder capsule, and coracoacromial ligament.

    Day 1 Pre, Day 1 Post, Day 2

  • Subjective Shoulder Stiffness (Visual Analogue Scale)

    Using Visual Analogue scale to measure participant's subjective measure of shoulder stiffness. Scores range from 0 to 10, with 0 being "Not stiff at all" and 10 being "Very stiff."

    Day 1 Pre, Day 2

Study Arms (2)

OMT Intervention, then Rest

EXPERIMENTAL

10 subjects will be randomized to begin with the dominant shoulder. Investigators will measure baseline outcomes on the dominant shoulder, apply OMT treatment, measure post treatment outcomes on dominant shoulder, a 5-minute rest period as a washout period, then proceed to measure baseline measures on non-dominant shoulder, a rest that is equivalent to the time needed for OMT treatment, ending with post measurements on the non-dominant shoulder.

Other: Osteopathic Manipulative Treatment-Spencer's Technique (Modified)Other: Rest

Rest, then OMT Intervention

EXPERIMENTAL

10 subjects will be randomized to begin with the non-dominant shoulder. Investigators will measure baseline outcomes on the non-dominant shoulder, a rest period equivalent to the time needed for OMT treatment, measure post treatment outcomes on non-dominant shoulder, a 5-minute rest period as a washout period, then proceed to measure baseline measures on dominant shoulder, provide OMT treatment, ending with post measurements on the dominant shoulder.

Other: Osteopathic Manipulative Treatment-Spencer's Technique (Modified)Other: Rest

Interventions

Combination OMT approach utilizing Muscle Energy Technique (MET), Articulatory Technique (ART), and Myofascial Release (MFR). It is a series of direct OMT addressing the barrier of somatic dysfunction (SD) with the goal of restoring neurovascular balance and improved motion of the shoulder girdle and glenohumeral joint. Utilizing these three OMT techniques, the practitioner attempts restoration of glenohumeral joint motion using shoulder extension, flexion, circumduction with compression, circumduction with distraction, abduction, adduction, external rotation, internal rotation, and distraction in abduction. The study uses a modified version of the Spencer technique, done in the seated position for patient comfort, as well as adding to the treatment sequence: latissimus dorsi, pectoralis minor-major, serratus anterior, and rhomboid major-minor. Adding these muscles into treatment will help to address and correct sternoclavicular joint SD, acromioclavicular joint SD, and scapular SD.

OMT Intervention, then RestRest, then OMT Intervention
RestOTHER

10 minute rest period.

OMT Intervention, then RestRest, then OMT Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male and female subjects 18-50 years old

You may not qualify if:

  • prior shoulder surgery or injury to the reported dominant throwing arm
  • shoulder pain in the reported dominant throwing arm within the last 6 months
  • diagnosis cervical radiculopathy or pinched nerve in the neck
  • connective tissue or muscle disorders
  • known pregnancy
  • tobacco use
  • known diabetes or prediabetes
  • allergy to ultrasound gel (propylene glycol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Via College of Osteopathic Medicine-Auburn

Auburn, Alabama, 36832, United States

RECRUITING

Related Publications (8)

  • Knebl JA, Shores JH, Gamber RG, Gray WT, Herron KM. Improving functional ability in the elderly via the Spencer technique, an osteopathic manipulative treatment: a randomized, controlled trial. J Am Osteopath Assoc. 2002 Jul;102(7):387-96.

    PMID: 12138953BACKGROUND
  • Iqbal M, Riaz H, Ghous M, Masood K. Comparison of Spencer muscle energy technique and Passive stretching in adhesive capsulitis: A single blind randomized control trial. J Pak Med Assoc. 2020 Dec;70(12(A)):2113-2118. doi: 10.5455/JPMA.23971.

    PMID: 33475581BACKGROUND
  • Haveela, B., Praveen Dowle, and P. Chandrasekhar.

    BACKGROUND
  • Yamaguchi K, Sher JS, Andersen WK, Garretson R, Uribe JW, Hechtman K, Neviaser RJ. Glenohumeral motion in patients with rotator cuff tears: a comparison of asymptomatic and symptomatic shoulders. J Shoulder Elbow Surg. 2000 Jan-Feb;9(1):6-11. doi: 10.1016/s1058-2746(00)90002-8.

    PMID: 10717855BACKGROUND
  • Kunz P, Mick P, Gross S, Schmidmaier G, Zeifang F, Weber MA, Fischer C. Contrast-Enhanced Ultrasound (CEUS) as Predictor for Early Retear and Functional Outcome After Supraspinatus Tendon Repair. J Orthop Res. 2020 May;38(5):1150-1158. doi: 10.1002/jor.24535. Epub 2019 Dec 2.

    PMID: 31769543BACKGROUND
  • Matava MJ, Purcell DB, Rudzki JR. Partial-thickness rotator cuff tears. Am J Sports Med. 2005 Sep;33(9):1405-17. doi: 10.1177/0363546505280213.

    PMID: 16127127BACKGROUND
  • Lawrence RL, Moutzouros V, Bey MJ. Asymptomatic Rotator Cuff Tears. JBJS Rev. 2019 Jun;7(6):e9. doi: 10.2106/JBJS.RVW.18.00149.

    PMID: 31246863BACKGROUND
  • Coren S. Measurement of handedness via self-report: the relationship between brief and extended inventories. Percept Mot Skills. 1993 Jun;76(3 Pt 1):1035-42. doi: 10.2466/pms.1993.76.3.1035.

    PMID: 8321574BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Cawley, DC, MSHS, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Two by Two cross-over trial. Measurements will be taken on both shoulders with only the dominant shoulder receiving osteopathic manipulative treatment (OMT). The order in which the measurements and OMT treatment is performed will be randomized. The cross-over design allows for the opportunity to estimate 3 components, the possible effect of ultrasound measurement on the outcomes even when OMT is not performed, the combined effect of OMT and ultrasound measurements on outcomes, and an adjusted estimate OMT treatment effect removing any ultrasound effects if those effects exist. Change scores for all outcomes will be calculated per shoulder and then a comparison between change scores will be conducted using a paired design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

August 15, 2023

Primary Completion

March 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations