PNF in Subacromial Impingement Syndrome

June 28, 2021 updated by: Ertuğrul Demirdel, Ankara Yildirim Beyazıt University

The Effects of Different Proprioceptive Neuromuscular Facilitation Patterns on Pain, Postural Changes and Functionality in Patients With Subacromial Impingement Syndrome: A Randomized Controlled Trial

Although proprioceptive neuromuscular facilitation (PNF) techniques have been used in the treatment of different shoulder problems, PNF techniques in scapular and upper trunk patterns with extremity pattern have not been considered as a possible option for the treatment of Subacromial Impingement Syndrome (SIS). The aim of this study was to evaluate the effects of different PNF patterns in SIS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized controlled trial was conducted in the Outpatient Clinic of a Physiotherapy and Rehabilitation Department in Ankara, Turkey. The demographic and clinical characteristics of the patients were recorded. Voluntary patients with SIS were regarded as eligible for the study if they met the inclusion criteria. Pain, posture and functionality were assessed before and after intervention. Patients who met the inclusion criteria and agreed to participate were randomly allocated to Group 1 [Conventional therapy (CT)], Group 2 [CT+ PNF in extremity pattern] and Group 3 [CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns]. A simple randomization method was used with opaque sealed envelopes containing "A", "B" or "C". Group allocation was performed by an independent therapist, not involved in the study. All patients received physiotherapy for approximately 60 mins each session, 3 sessions per week for 6 weeks. Conventional therapy consisted of cold pack (15 minutes); pulsed ultrasound therapy (1 watt/cm², 3 MHz, 1:2 pulsed mode; 3 minutes); transcutaneous electrical nerve stimulation (60-120 Hz; 20 minutes) and exercises (20 minutes). The exercises included stretching, strengthening and posture exercises. The exercises, and the duration and intensity of conventional physiotherapy were selected according to previous studies which showed that a physiotherapy program 3 times a week for 6 weeks was effective in improving function and relieving pain in SIS. The physiotherapy program was applied to all patients at the same intensity by the same physiotherapist and patients did the exercises every day throughout the 6-week period. The patients were also advised to avoid overhead activities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients diagnosed with SIS,
  • aged between 18 and 65 years,
  • shoulder pain ongoing for more than four weeks,
  • loss of active shoulder motion or painful ROM,
  • no treatment related to the shoulder in the last 6 months.

Exclusion Criteria:

  • history of frozen shoulder,
  • disorders of the acromioclavicular joint,
  • possession of a curved or hooked acromion,
  • shoulder instability,
  • degenerative arthritis of the glenohumeral joint,
  • calcifying tendonitis,
  • post-traumatic disorders,
  • shoulder surgery and/or elbow, hand, wrist and cervical spine disorders,
  • diseases that can cause positional vertigo.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Conventional therapy (CT)
Cold pack (15 minutes); pulsed ultrasound therapy (1 watt/cm², 3 MHz, 1:2 pulsed mode; 3 minutes); transcutaneous electrical nerve stimulation (60-120 Hz; 20 minutes) and exercises (20 minutes). The exercises included stretching, strengthening and posture exercises.
Other: Conventional therapy
EXPERIMENTAL: CT+ PNF in extremity pattern
PNF in the extremity pattern, were instructed to actively move through the PNF flexion-abduction-external rotation diagonal pattern for 10 repetitions with manual facilitation and the treatment was performed within the range in which pain did not occur. Rhythmic stabilization and repeated contractions were applied from the PNF techniques.
Other: Conventional therapy
Other: CT+ PNF in extremity pattern
EXPERIMENTAL: CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns
PNF in scapula and upper trunk patterns in addition to PNF in the extremity pattern. The scapular pattern application was performed by positioning the affected extremity in a relaxed position above the stable side in the side-lying position. Rhythmic stabilization and repeated contractions were applied from the anterior-elevation position in the direction of posterior-depression. Extension, lateral flexion and rotation to the affected side were performed in the trunk patterns in rhythmic stabilization and repeated contractions.
Other: Conventional therapy
Other: CT+ PNF in extremity pattern
Other: CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Scapular stability
Time Frame: Change from baseline scapular stability at 6 weeks
The lateral scapular slide test (LSST) was applied to evaluate scapular stability. In the first position (LSST 1), both arms are relaxed at the sides with the glenohumeral joint in a neutral position. In the second position (LSST 2), the subject places both hands on the ipsilateral hips with the humerus in medial rotation in 45° of abduction in the coronal plane. In position 3 (LSST 3), the subject actively extends both elbows and places the upper extremities in a position of maximum medial rotation in 90° of abduction in the coronal plane. The inferomedial angle of the scapula is palpated and marked on both the affected and unaffected sides, and the spinous process of the thoracic vertebra in the same horizontal plane (the reference vertebra) is then marked. The measurements from the reference point on the spine to the medial border of the scapula are measured on both sides in all 3 test positions.
Change from baseline scapular stability at 6 weeks
Anterior tilt of the head
Time Frame: Change from baseline anterior tilt of the head at 6 weeks
The distance was measured from the sternal notch to the tip of the chin with a tape measure.
Change from baseline anterior tilt of the head at 6 weeks
Rounded shoulder
Time Frame: Change from baseline rounded shoulder at 6 weeks
The subject stood in a relaxed position with their heels against a wall. The posterolateral acromion was marked and the ruler was held square. The measurement was taken from the acromion to the wall behind the subject to determine the amount of forward displacement.
Change from baseline rounded shoulder at 6 weeks
Thoracic kyphosis
Time Frame: Change from baseline thoracic kyphosis at 6 weeks
The gravity-dependent inclinometer (BASELINEᴿ Bubble inclinometer-USA) was used to measure kyphosis. In the first measurement, the inclinometer was placed over the region of the 1st and 2nd thoracic spinous processes and in the second, over the region of the 12th thoracic and 1st lumbar spinous processes. The total of the angles in each measurement was recorded.
Change from baseline thoracic kyphosis at 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain severity
Time Frame: Just before the treatment and at the end of 6-week treatment
Patients' pain will be assessed for three different situations: "at rest", "at activity" and "at night" before and after treatment. The patient is asked to mark the severity of pain on the 10 cm horizontal line [left end(0) = no pain, right end(10)= unbearable pain ]. Data is measured with a standard ruler and results are recorded in centimeters (cm).
Just before the treatment and at the end of 6-week treatment
Functional status
Time Frame: Just before the treatment and at the end of 6-week treatment
The numerically-scaled Shoulder Pain and Disability Index, a 13-item self-administered instrument measuring shoulder functional status, was used.
Just before the treatment and at the end of 6-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015 (U.S. NIH Grant/Contract: American Sleep Medicine Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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