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TENS Versus Ultrasound With Exercise for Mechanical Neck Pain.

21. července 2026 aktualizováno: BUSHRA NASEEM, Dow University of Health Sciences

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

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

Intervenční

Zápis (Odhadovaný)

44

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Dr. Saba Aijaz Ali, Physiotherapist, MSAPT
  • Telefonní číslo: +923002886769
  • E-mail: saba.aijaz@duhs.edu.pk

Studijní místa

    • Sindh
      • Karachi, Sindh, Pákistán, 75300
        • Nábor
        • Dow University of Health Sciences

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

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

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

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
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
Visual Analog Scale (VAS) for Pain
Časové okno: Baseline and after 2 weeks of treatment.
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.
Baseline and after 2 weeks of treatment.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Muscle strength measured using Manual Muscle Testing (MMT)
Časové okno: Baseline and after 2 weeks of treatment.
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.
Baseline and after 2 weeks of treatment.
Pressure pain threshold measured using an algometer
Časové okno: Baseline and after 2 weeks of treatment.
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).
Baseline and after 2 weeks of treatment.
Neck disability measured using the Neck Disability Index (NDI)
Časové okno: Baseline and after 2 weeks of treatment.
The Neck Disability Index (NDI) scores range from 0 to 50, where higher scores indicate greater neck disability (worse outcome).
Baseline and after 2 weeks of treatment.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Bushra naseem, DPT, MSAPT (In progress), DUHS

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. srpna 2026

Primární dokončení (Odhadovaný)

15. září 2026

Dokončení studie (Odhadovaný)

15. září 2026

Termíny zápisu do studia

První předloženo

8. května 2026

První předloženo, které splnilo kritéria kontroly kvality

21. července 2026

První zveřejněno (Aktuální)

23. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data (IPD) will not be shared publicly due to confidentiality and ethical considerations. The data collected in this study will contain participant health information and will only be used for analysis and publication of study results by the Principal investigator. Access to the dataset will be restricted to ensure participant privacy and compliance with institutional ethical guidelines.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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