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Completed

NCT Number: NCT03468049

Effect of Allium Cepa in the Management of Shoulder Pain Post Stroke

One of the disabling consequences of stroke is hemipleic shoulder pain. Hemiplegic shoulder pain could be most important hinderance to upper extremity function after stroke . Evidence for rehabilitation approaches for shuolder pain suggested diverse approaches with strong need for further studies. This study planned to investigate the effect of Allium Cepa in the management of shoulder pain post stroke using four arms of the studying with three intervention groups and control group All participants who met study inclusion criteria and gave their consent shall be assessed at baseline for impairment (Fugl Meyer Assessment), activity limitation (Brief Pain Inventory) and participation restrictions (Stroke Impact Scale)

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Amina Kano Teaching Hospital

Kano, +234, Nigeria

About this study

Globally, stroke is the second most common cause of death and a major cause of disability. One of the disabling consequences of stroke is hemipleic shoulder pain which on its own could result in disability. Physical therapy is an integral part of post stroke rehabilitation, and plays an important role in the prevention and treatment of hemiplegic shoulder pain. Generally, patients with pain will most likely experience greater cognitive impairment and functional decline, lower quality of life, fatigue, depression and often poorly cooperate in rehabilitation. It was reported from a study that the ideal management of hemiplegic shoulder pain is to prevent it from happening in the first place, once the patient developed pain, resultant anxiety and over protection will follow. Hemiplegic shoulder pain can also interfere with arm recovery, reduce activity of daily living and markedly hinder rehabilitation.Similarly, a study have reported shoulder pain to cause considerable distress, discomfort, interference with rehabilitation, delay in discharge and that it is generally poorly managed. A recently updated Evidence-Based Review of Stroke Rehabilitation (EBRSR) on painful hemiplegic shoulder summarised 19 key points about painful hemiplegic shoulder; while all the 19 points are essential, the need for these study is closely related by some of these points these include Aggressive range of motion exercises (i.e. pullies) results in a markedly increased incidence of painful shoulder; a gentler range of motion program is preferred. Adding ultrasound treatments does not appear to improve shoulder range of motion, Treatment with surface neuromuscular electrical stimulation (NMES) early (< 6 months) post-stroke may reduce shoulder subluxation but not pain associated with shoulder hemiplegia. Surface NMES delivered after 6 months provides no additional benefits over conventional therapy on shoulder subluxation. Intramuscular NMES however, has been found to reduce shoulder pain up to 12 months post-therapy, Strapping/taping the hemiplegic shoulder does not appear to improve upper limb function, but may reduce pain, Further research is needed to determine the benefits of aromatherapy in combination with acupressure regarding its effects on reducing pain caused by shoulder hemiplegia and Massage therapy may reduce hemiplegic shoulder pain, anxiety, and other physiological functions (i.e. blood pressure, and heart rate) however, more research is still warranted. This study will therefore investigat the effect of Allium cepa(onion) in the management of shoulder pain post stoke.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants who had hemiplegic shoulder pain after stroke with age range of 18 years and above who are able to express pain level and communicate in general

Exclusion criteria

  • Stroke survivors with significant cognitive impairment (< 18 on a mini mental scale) and language impairment that would prevent the patient from answering questions reliably.
  • Stroke survivors who had sustained shoulder pain caused by condition other than hemiplegia such as fracture, vertebral origin, dislocation, inflammatory arthritis (rheumatoid and gout) and fibromyalgia.
  • Participants who exhibit allergy to Allium Cepa (skin sensitivity or finds the odor offensive).
  • Participants who do not agree to use Allium Cepa

Treatment and study plan

Topical App. of Allium Cepa Extract

Biological

Topical Application of Allium Cepa Extract (oil)

Phonophoresis of Allium Cepa Extract

Biological

Phonophoresis of Allium Cepa Extract (oil)

Raw Mashed Allium Cepa Application

Biological

Raw Allium Cepa (onion bulb) Mashed

Standard Physiotherapy Group (SPG)

Other

This will consist of Massage and therapeutic exercise for the management of shoulder pain post stroke

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 1 minute

    This was used to assess pain intensity of participants in this study. It is usually 10cm (100mm [0-4mm no pain, 5-44mm mild pain, 45-74mm moderate pain and 75-100mm severe pain] in length with two verbal descriptors for the two symptoms extremes. The score ranges from 0-10, with 0 being no pain and 10 pain as bad as possible or worst imaginable pain. Verbal descriptors and numbers at the intermediate points are not recommended in order to avoid clustering of scores around a preferred numeric value.

  2. Fugl Meyer Assessment Scale (upper extremity)

    Time frame: 15 minutes

    This was used to assess the recovery of shoulder joint functional outcome. The items are scored on a 3 points ordinal scale [0 (cannot perform), 1(performs partially) and 2 (performs fully)] with maximum score of 226 points. It assesses five domains which include motor function (for upper extremity = 66 and lower extremity = 34), sensory function = 24, balance = 14, joint range of motion = 44 and joint pain = 44. Interpretation of fugyl meyer assessment is as follows 0-35 = very severe, 36-55 = severe, 56-79 = moderate and >79 mild for motor assessment.

Secondary outcomes

  1. Stroke Impact Scale

    Time frame: 15 minutes

    this will be use to assess participant quality of life. It is a 59 items measure divided into eight domains namely; strength (4 items), hand function (5 items), ADL/IADL (10 items), mobility (9 items), communication (7 items), emotion (9 items), memory and thinking (7 items) and participation/role function (8 items). Each item is rated in a 5-points likert scale in terms of the difficulty the patient has experienced in completing the item. Summative score are generated for each domain, score range from 0-100. Stroke Impact Scale has an extra questions on stroke recovery that ask the client rate of recovery on a scale of 0-100, with 0 being no recovery and 100 full recovery

Sponsors and collaborators

Lead sponsor

Bayero University Kano, Nigeria

Other

Collaborators

  • Physiotherapy Associates

Registry information

Official study title

Effect of Allium Cepa (Onion)in the Management of Shoulder Pain Post Stroke : A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 16, 2018
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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