- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07723586
TENS Versus Ultrasound With Exercise for Mechanical Neck Pain.
Therapeutic Benefit of Two Modalities TENS and Ultrasound Along With Exercises in the Management of Mechanical Neck Pain; A Randomized Clinical Trial
This randomized clinical trial aims to compare the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) and therapeutic ultrasound, both combined with therapeutic exercises, in the management of mechanical neck pain.
A total of 44 participants male and female both with mechanical neck pain will be randomly allocated into two equal groups at the physiotherapy OPD of DOW Institute of Physical Medicine & Rehabilitation, Dow University of Health Sciences, Karachi. Group A will receive TENS with exercise, while group B will receive ultrasound with the same exercise protocol.
Both groups will receive 9 treatment sessions over 2 weeks. Outcomes will include pain intensity, functional disability, and cervical range of motion, assessed before and after the intervention.
Přehled studie
Postavení
Podmínky
Detailní popis
Mechanical Neck Pain is described as immediate or prolonged discomfort in cervical and shoulder regions, starting from the base of skull to the spine of scapula, this discomfort may extend down the arms and leading to reduction in the range of motion in the neck region and it occurred without any prior history of trauma, infection or systematic issues like fractures. Nonspecific neck pain is because of postural and mechanical reasons also known as Mechanical Neck Pain. Neck problems are not dangerous but these issues may cause discomfort and firmness. Much of the time neck pain is because of poor posture and flawed ergonomics at work area. Across various countries including Pakistan, Australia, the USA (New York), China, Brazil, and Central Saudi Arabia studies have identified neck pain prevalence among medical students ranging from 8.23% to 65%. Neck pain prevalence most commonly increases with age and greater among women as compared to men. According to studies 30%, 43% men and women respectively once in their lifetime experience neck pain, out of them10% men and 17% women experience chronic pain. Studies reported the 2nd most common musculoskeletal cause of disability globally. It is estimated that there are approximately 12 cases of Mechanical Neck Pain (MNP) per 1000 individuals seeking medical attention per year. Neck pain is a most frequent reason to seek medical attention from healthcare providers. Across the general population, neck pain affects 14% to 71% adults at various stages in their lives, among north Europeans 1-year greater prevalence as compared to Asian population. In general, worldwide population, 25% women and 16% men in Sweden experience neck pain annually. Iran reported 15% prevalence of neck pain in adults. While the exact cause of neck pain remains unclear, it is widely recognized as having a miscellaneous origin. Research indicates a strong correlation with factors such as depression, anxiety, migraines, sedentary lifestyle, disrupted sleep patterns, and smoking. The rising interest in neck pain because of its global prevalence which is 4.9%. Neck pain holds the 4th positions among condition causing disability when assessed in terms of years lived with some sort of pain and disability. Neck pain is responsible for causing disabilities of various severities and major cause of substantial medical expenses, productivity losses and economic burden.
Methodology:
Participants who are diagnose and referred to the Physiotherapy Outpatient Department (OPD) of the DOW Institute of Physical Medicine & Rehabilitation at Dow University of Health Sciences, OJHA Campus, will be included in the study. All eligible participants will be thoroughly informed about the study through a structured Informed Consent Form. The researcher will introduce herself, explain the purpose, procedures, potential risks, and benefits of the study.
Participants will be allowed ample time to read the form, ask questions, and clarify any doubts. Those willing to participate will be asked to sign the consent form or provide a thumb impression. The screening and initial identification of eligible participants will be supervised by a senior physiotherapist. The informed consent process ensures compliance with ethical principles including autonomy, confidentiality, and the right to withdraw at any stage of the study without any penalty or impact on their ongoing care.
Sample size of 44 participants will be divided into two equal groups through simple random sampling technique through number generator table to ensure each participant has an equal chance of being selected and reduce selection biasness. The method used in the study comprise single blinded methodology.
Group A include 22 participants both male and females, will receive TENS (15 min), heating pad (10 min), followed by cervical active stretching (~4 min) and isometric exercises (~3 min), making a treatment subtotal of ~30 minutes, with the remaining time used for supervision, education, rest, and documentation (total 45 min/session).
Group B also include 22 participants, will receive therapeutic Ultrasound (10 min), heating pad (10 min), the same stretching (~4 min) and isometric exercises (~3 min), totaling ~27 minutes of treatment plus ~15 minutes for supervision and documentation (45 min/session).
Both groups will undergo 9 sessions over 2 weeks (6 consecutive sessions in week 1 and 3 alternate-day sessions in week 2).
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Bushra Naseem, physiotherapist
- Telefonní číslo: +923131175294
- E-mail: naseembushra321@gmail.com
Studijní záloha kontaktů
- Jméno: Dr. Saba Aijaz Ali, Physiotherapist, MSAPT
- Telefonní číslo: +923002886769
- E-mail: saba.aijaz@duhs.edu.pk
Studijní místa
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Sindh
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Karachi, Sindh, Pákistán, 75300
- Nábor
- Dow University of Health Sciences
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Diagnosed and referred patients with mechanical neck pain.
- Participants with subacute or chronic neck pain.
- Participants willing to participate in the study.
- Participants with a Visual Analog Scale (VAS) pain score greater than 5 (moderate to severe pain).
Exclusion Criteria:
- Participants with other musculoskeletal disorders, including rheumatoid arthritis, cervical spondylosis, spondylolisthesis, cervical radiculopathy, malignancy, or neurological disorders.
- Participants with a history of trauma or whiplash injury.
- Participants with chronic pain conditions such as fibromyalgia.
- Participants with vertigo or dizziness.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Komparátor placeba: Group B (Ultrasound with Exercise)
Participants in this group will receive therapeutic ultrasound for 10 minutes, heating therapy for 10 minutes, followed by cervical active stretching and isometric exercises.
Each session will last approximately 45 minutes.
A total of 9 sessions will be provided over 2 weeks.
|
Participants will receive Transcutaneous Electrical Nerve Stimulation (TENS) for 15 minutes, heating therapy for 10 minutes, followed by cervical active stretching and isometric exercises during each treatment session. A total of 9 sessions will be conducted over 2 weeks. Participants will receive therapeutic ultrasound for 10 minutes, heating therapy for 10 minutes, followed by cervical active stretching and isometric exercises during each treatment session. A total of 9 sessions will be conducted over 2 weeks. |
|
Experimentální: Group A (TENS with Exercise)
Participants will receive Transcutaneous Electrical Nerve Stimulation (TENS) for 15 minutes, heating therapy for 10 minutes, followed by cervical active stretching and isometric exercises.
Each session will last approximately 45 minutes.
A total of 9 sessions will be provided over 2 weeks.
|
Participants will receive Transcutaneous Electrical Nerve Stimulation (TENS) for 15 minutes, heating therapy for 10 minutes, followed by cervical active stretching and isometric exercises during each treatment session. A total of 9 sessions will be conducted over 2 weeks. Participants will receive therapeutic ultrasound for 10 minutes, heating therapy for 10 minutes, followed by cervical active stretching and isometric exercises during each treatment session. A total of 9 sessions will be conducted over 2 weeks. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Visual Analog Scale (VAS) for Pain
Časové okno: Baseline and after 2 weeks of treatment.
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Visual Analog Scale (VAS) for Pain: Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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Baseline and after 2 weeks of treatment.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Muscle strength measured using Manual Muscle Testing (MMT)
Časové okno: Baseline and after 2 weeks of treatment.
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Manual Muscle Testing (MMT) grades muscle strength on a 0 to 5 scale, where 0 indicates no visible or palpable muscle contraction and 5 indicates normal muscle strength against full resistance.
Higher scores indicate better muscle strength.
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Baseline and after 2 weeks of treatment.
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Pressure pain threshold measured using an algometer
Časové okno: Baseline and after 2 weeks of treatment.
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Pressure Pain Threshold (PPT) is measured using an algometer and recorded in Newtons (N).
The pressure pain threshold is the amount of force at which pressure first becomes painful.
Higher values indicate a higher pressure pain threshold (better outcome/less pain sensitivity).
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Baseline and after 2 weeks of treatment.
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Neck disability measured using the Neck Disability Index (NDI)
Časové okno: Baseline and after 2 weeks of treatment.
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The Neck Disability Index (NDI) scores range from 0 to 50, where higher scores indicate greater neck disability (worse outcome).
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Baseline and after 2 weeks of treatment.
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Bushra naseem, DPT, MSAPT (In progress), DUHS
Publikace a užitečné odkazy
Obecné publikace
- Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392.
- Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
- Gumuscu BH, Kisa EP, Kara Kaya B, Muammer R. Comparison of three different exercise trainings in patients with chronic neck pain: a randomized controlled study. Korean J Pain. 2023 Apr 1;36(2):242-252. doi: 10.3344/kjp.22371. Epub 2023 Mar 21.
- Puntumetakul R, Chatprem T, Saiklang P, Phadungkit S, Kamruecha W, Sae-Jung S. Prevalence and Associated Factors of Clinical Myelopathy Signs in Smartphone-Using University Students with Neck Pain. Int J Environ Res Public Health. 2022 Apr 17;19(8):4890. doi: 10.3390/ijerph19084890.
- Rodriguez-Huguet M, Gil-Salu JL, Rodriguez-Huguet P, Cabrera-Afonso JR, Lomas-Vega R. Effects of Myofascial Release on Pressure Pain Thresholds in Patients With Neck Pain: A Single-Blind Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Jan;97(1):16-22. doi: 10.1097/PHM.0000000000000790.
- Weleslassie GG, Meles HG, Haile TG, Hagos GK. Burden of neck pain among medical students in Ethiopia. BMC Musculoskelet Disord. 2020 Jan 8;21(1):14. doi: 10.1186/s12891-019-3018-x.
- Qing W, Shi X, Zhang Q, Peng L, He C, Wei Q. Effect of Therapeutic Ultrasound for Neck Pain: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2021 Nov;102(11):2219-2230. doi: 10.1016/j.apmr.2021.02.009. Epub 2021 Mar 17.
- Vas J, Perea-Milla E, Mendez C, Sanchez Navarro C, Leon Rubio JM, Brioso M, Garcia Obrero I. Efficacy and safety of acupuncture for chronic uncomplicated neck pain: a randomised controlled study. Pain. 2006 Dec 15;126(1-3):245-55. doi: 10.1016/j.pain.2006.07.002. Epub 2006 Aug 23.
- Hany Sedeek Abousenna MM, Mohamed Shalaby AS, Chahal A, Shaphe A. A comparison of low dose ultrasound and far-infrared therapies in patients with mechanical neck pain. J Pak Med Assoc. 2021 Feb;71(2(A)):397-401. doi: 10.47391/JPMA.190.
- Siddiqui M, Akhter S, Baig AAM. Effects of autogenic and reciprocal inhibition techniques with conventional therapy in mechanical neck pain - a randomized control trial. BMC Musculoskelet Disord. 2022 Jul 25;23(1):704. doi: 10.1186/s12891-022-05668-0.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB-4390/DUHS/Approval/2025/84
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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