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Subacromial Impingement SyndromeNCT04794933

PNF in Subacromial Impingement Syndrome

A study testing Conventional therapy, CT+ PNF in extremity pattern and CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns in people with Subacromial Impingement Syndrome, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Subacromial Impingement Syndrome
What is being tested?
Conventional therapy, CT+ PNF in extremity pattern and CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
Dec 2013to Apr 2015
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 9Show fewer
  • post-traumatic disorders,
  • shoulder surgery and/or elbow, hand, wrist and cervical spine disorders,
  • diseases that can cause positional vertigo.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Conventional therapy, CT+ PNF in extremity pattern, CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns
Keywords
subacromial impingement, posture, pain, Proprioceptive Neuromuscular Facilitation
Medical subject headings
Shoulder Impingement Syndrome, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional therapyOther

  • CT+ PNF in extremity patternOther

  • CT+ PNF in extremity pattern+PNF in scapula and upper trunk patternsOther

Study groups in NCT04794933
Study groupRoleWhat they receive
Conventional therapy (CT)Active comparatorCold 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.
Receives: Other: Conventional therapy
CT+ PNF in extremity patternExperimentalPNF 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.
Receives: Other: Conventional therapy; Other: CT+ PNF in extremity pattern
CT+ PNF in extremity pattern+PNF in scapula and upper trunk patternsExperimentalPNF 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.
Receives: Other: Conventional therapy; Other: CT+ PNF in extremity pattern; Other: CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scapular stability

    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.

    Measured: Change from baseline scapular stability at 6 weeks

  2. Anterior tilt of the head

    The distance was measured from the sternal notch to the tip of the chin with a tape measure.

    Measured: Change from baseline anterior tilt of the head at 6 weeks

  3. Rounded shoulder

    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.

    Measured: Change from baseline rounded shoulder at 6 weeks

  4. Thoracic kyphosis

    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.

    Measured: Change from baseline thoracic kyphosis at 6 weeks

Secondary outcomes (2)
  1. Pain severity

    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).

    Measured: Just before the treatment and at the end of 6-week treatment

  2. Functional status

    The numerically-scaled Shoulder Pain and Disability Index, a 13-item self-administered instrument measuring shoulder functional status, was used.

    Measured: Just before the treatment and at the end of 6-week treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2021
  2. Study startDec 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

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
Parallel groups
Model description
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 \[CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns\].
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04794933
Sponsor's protocol ID
2015
Status last verified
Jun 2021
First submitted
9 Mar 2021
Last updated
30 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cools AM, Struyf F, De Mey K, Maenhout A, Castelein B, Cagnie B. Rehabilitation of scapular dyskinesis: from the office worker to the elite overhead athlete. Br J Sports Med. 2014 Apr;48(8):692-7. doi: 10.1136/bjsports-2013-092148. Epub 2013 May 18.

    PubMed 23687006
  • Escamilla RF, Yamashiro K, Paulos L, Andrews JR. Shoulder muscle activity and function in common shoulder rehabilitation exercises. Sports Med. 2009;39(8):663-85. doi: 10.2165/00007256-200939080-00004.

    PubMed 19769415
  • Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.

    PubMed 12804509
  • Gumina S, Di Giorgio G, Postacchini F, Postacchini R. Subacromial space in adult patients with thoracic hyperkyphosis and in healthy volunteers. Chir Organi Mov. 2008 Feb;91(2):93-6. doi: 10.1007/s12306-007-0016-1. Epub 2008 Mar 3.

    PubMed 18320381
  • Hanratty CE, McVeigh JG, Kerr DP, Basford JR, Finch MB, Pendleton A, Sim J. The effectiveness of physiotherapy exercises in subacromial impingement syndrome: a systematic review and meta-analysis. Semin Arthritis Rheum. 2012 Dec;42(3):297-316. doi: 10.1016/j.semarthrit.2012.03.015. Epub 2012 May 18.

    PubMed 22607807
  • Hickey D, Solvig V, Cavalheri V, Harrold M, Mckenna L. Scapular dyskinesis increases the risk of future shoulder pain by 43% in asymptomatic athletes: a systematic review and meta-analysis. Br J Sports Med. 2018 Jan;52(2):102-110. doi: 10.1136/bjsports-2017-097559. Epub 2017 Jul 22.

    PubMed 28735288
  • Holmgren T, Hallgren HB, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. Br J Sports Med. 2014 Oct;48(19):1456-7. doi: 10.1136/bjsports-2014-e787rep.

    PubMed 25213604
  • Hunter DJ, Rivett DA, McKeirnan S, Smith L, Snodgrass SJ. Relationship Between Shoulder Impingement Syndrome and Thoracic Posture. Phys Ther. 2020 Apr 17;100(4):677-686. doi: 10.1093/ptj/pzz182.

    PubMed 31825488

Questions about this trial

What is this clinical trial studying?

A study testing Conventional therapy, CT+ PNF in extremity pattern and CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns in people with Subacromial Impingement Syndrome, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

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 5 inclusion and 9 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 30 Jun 2021. 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 Turkey (Türkiye). 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. 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?

Scapular stability (time frame: Change from baseline scapular stability at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04794933, which also lists 8 linked publications.

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 30 Jun 2021.

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