Shoulder PainNCT03416556
Manual Therapy in Chronic Shoulder Pain Treatment
A study testing Mobilization to the glenohumeral joint, The manual contact condition and No-contact condition in people with Shoulder Pain, run by University of Alcala at 1 site in Spain.
Trial summary
Background: Passive oscillatory mobilizations are often employed by physiotherapists to reduce shoulder pain and increase function. However, there is little data about the neurophysiological effects of these mobilizations. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Mobilization to the glenohumeral joint, The manual contact condition and No-contact condition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2018to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of chronic shoulder pain lasting ≥3 months.
- Play overhead sport regularly.
Who cannot join
- Had a non-musculoskeletal origin of shoulder pain.
- Previous surgery to the shoulder complex.
- Frozen shoulder.
- Any co-existing inflammatory, infectious or neurological condition.
- The patient from physiotherapy treatment.
- Any evidence of pain referred from the cervical spine to the shoulder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Initial Effects on Pain, Pain Sensitivity, Range of Motion and Muscle Strength of an Anteroposterior Mobilization of the Glenohumeral Joint in Overhead Athletes With Chronic Shoulder Pain
Background: Passive oscillatory mobilizations are often employed by physiotherapists to reduce shoulder pain and increase function. However, there is little data about the neurophysiological effects of these mobilizations.
Objectives: To investigate the initial effects of an anteroposterior (AP) shoulder joint mobilization on measures of pain and function in overhead athletes with chronic shoulder pain.
Read the detailed description
Design: Double-blind, controlled, within-subjects repeated-measures design Method: Thirty-one overhead athletes with chronic shoulder pain participated. The effects of a 9-min, AP mobilization of the glenohumeral joint were compared with manual contact and no-contact interventions. Pressure pain threshold (PPT), range of movement (ROM), muscle strength, self-reported pain, and disability were measured immediately before and after each intervention.
- Conditions
- Shoulder Pain
- Being tested
- Mobilization to the glenohumeral joint, The manual contact condition, No-contact condition
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization to the glenohumeral jointProcedure or surgery
Also called Joint Manipulation
The treatment condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder. In particular, a Grade III AP glide to the humeral head with the arm positioned in 90º of glenohumeral abduction and full internal rotation was used. The posterior gliding force to the humeral head was applied maintaining the glide at right angles to the plane of movement and at a frequency of 2 Hz which was controlled by means of a metronome. The arm was returned to its original position between each set.
The manual contact conditionProcedure or surgery
During the manual contact condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition. However, a simulated posterior glide was performed but with minimal pressure actually applied. The number of repetitions and sets were as per the treatment condition.
No-contact conditionOther
During the no-contact condition, the subject remained in the initial starting position thorough the entire session but there was no manual contact between the therapist and the participant. The total treatment time was the same as per the other conditions.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization to the glenohumeral joint | Experimental | This condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder Receives: Procedure: Mobilization to the glenohumeral joint |
| The manual contact condition | Sham comparator | In this condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition. Receives: Procedure: The manual contact condition; Other: No-contact condition |
| No-contact condition | No intervention | There was no manual contact between the therapist and the participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported shoulder pain
Participants were asked to indicate the intensity of their current shoulder pain using a numeric rating pain scale (NRPS). In this scale, 0 is not pain and 10 is the worse pain possible
Measured: Change from Baseline at 5 minutes after intervention
Secondary outcomes (4)
Shoulder disability
The DASH is comprised of 30 items (disability/symptom section) and two optional sections related to the impact of pathology on work and sports. Each item is scored from 1 to 5 with increasing values representing more severity of symptoms. The total score for the disability/symptoms section ranges from 30 to 150, but it is then transformed to a scale from 0 (better score possible) to 100 (worse score possible).
Measured: Change from Baseline at 24 hours after treatment
Shoulder range of movement (ROM)
Active elevation in the scapular plane and passive glenohumeral internal and external rotation were measured using a Standard BASELINE ® 12-inch plastic goniometer following previous guidelines. The 0 degrees of movement is worse and 180 degrees is the better
Measured: Change from Baseline at and 5 minutes after treatment
Shoulder muscles strength
Isometric strength of the shoulder internal and external rotator musculature was measured using a portable hand-held dynamometer (Nicholas Manual Muscle Tester, Lafayette Instruments, USA). Normal external rotation strength is 20 Newtons and 27 newton in internal rotation strength
Measured: Change from Baseline at 5 minutes after treatment
Pressure pain threshold (PPT)
The PPT was measured using an analogue Fisher algometer (Force Dial model FDK, Wagner Instruments) with a surface area at the round tip of 1cm2. The algometer probe tip was applied perpendicular to the skin at a rate of 1kg/cm2/s until the first onset of pain. The PPT value is specific in each subject.The minimal clinically important difference is 2Kg/cm
Measured: Change from Baseline at 5 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start15 Feb 2018
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, Dr, Principal investigator, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416556
- Sponsor's protocol ID
- H1496053548524
- Status last verified
- Mar 2018
- First submitted
- 11 Jan 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Initial Effects on Pain, Pain Sensitivity, Range of Motion and Muscle Strength of an Anteroposterior Mobilization of the Glenohumeral Joint in Overhead Athletes With Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT03416556
- Acronym / sponsor ID
- H1496053548524
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Passive oscillatory mobilizations are often employed by physiotherapists to reduce shoulder pain and increase function. However, there is little data about the neurophysiological effects of these mobilizations.
Objectives: To investigate the initial effects of an anteroposterior (AP) shoulder joint mobilization on measures of pain and function in overhead athletes with chronic shoulder pain.
Detailed description
Design: Double-blind, controlled, within-subjects repeated-measures design Method: Thirty-one overhead athletes with chronic shoulder pain participated. The effects of a 9-min, AP mobilization of the glenohumeral joint were compared with manual contact and no-contact interventions. Pressure pain threshold (PPT), range of movement (ROM), muscle strength, self-reported pain, and disability were measured immediately before and after each intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobilization to the glenohumeral joint | Experimental | Procedure: Mobilization to the glenohumeral jointThis condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder |
| The manual contact condition | Sham comparator | Procedure: The manual contact condition, Other: No-contact conditionIn this condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition. |
| No-contact condition | No intervention | –There was no manual contact between the therapist and the participant |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- History of chronic shoulder pain lasting ≥3 months.
- Play overhead sport regularly.
Key exclusion criteria (6 listed)
- Had a non-musculoskeletal origin of shoulder pain.
- Previous surgery to the shoulder complex.
- Frozen shoulder.
- Any co-existing inflammatory, infectious or neurological condition.
- The patient from physiotherapy treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilization to the glenohumeral jointAlso: Joint ManipulationThe treatment condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder. In particular, a Grade III AP glide to the humeral head with the arm positioned in 90º of glenohumeral abduction and full internal rotation was used. The posterior gliding force to the humeral head was applied maintaining the glide at right angles to the plane of movement and at a frequency of 2 Hz which was controlled by means of a metronome. The arm was returned to its original position between each set. | Procedure or surgery | Mobilization to the glenohumeral joint |
| The manual contact conditionDuring the manual contact condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition. However, a simulated posterior glide was performed but with minimal pressure actually applied. The number of repetitions and sets were as per the treatment condition. | Procedure or surgery | The manual contact condition |
| No-contact conditionDuring the no-contact condition, the subject remained in the initial starting position thorough the entire session but there was no manual contact between the therapist and the participant. The total treatment time was the same as per the other conditions. | Other | The manual contact condition |
Primary outcome
Self-reported shoulder pain
Time frame: Change from Baseline at 5 minutes after intervention
Participants were asked to indicate the intensity of their current shoulder pain using a numeric rating pain scale (NRPS). In this scale, 0 is not pain and 10 is the worse pain possible
4 secondary outcomes
Shoulder disability
Time frame: Change from Baseline at 24 hours after treatment
Shoulder range of movement (ROM)
Time frame: Change from Baseline at and 5 minutes after treatment
Shoulder muscles strength
Time frame: Change from Baseline at 5 minutes after treatment
Pressure pain threshold (PPT)
Time frame: Change from Baseline at 5 minutes after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Pecos-Martin, Dr principal investigator
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization to the glenohumeral joint, The manual contact condition and No-contact condition in people with Shoulder Pain, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported shoulder pain (time frame: Change from Baseline at 5 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.